Friday, November 20, 2009
Let Draeger Polaris Be Your Guiding Light
We are continuing to profile the latest gadgets that are being showcased at the Medica 2009 in Düsseldorf. This beautiful line of cold OR light systems, appropriately dubbed Polaris, comes from Drägerwerk AG & Co., a company better known to everyone as Dräger.
Details from the press release:
Compared with conventional light sources, the smaller LEDs of the Polaris system are considerably more energy-efficient than conventional light sources. An LED light source has a life span of about 30,000 hours (corresponding to about seven to ten years of service life in the operating room), while the life span of a conventional light source is about 1,000 hours (corresponding to about four months of service life in the operating room). The slight amount of lost heat from the LEDs is dispensed through the top of the housing.The different Polaris models are distinguished by their illuminating power. They can be used as an individual OR light or as a satellite in multiple-light systems, and can also be equipped with an integrated camera.
This new product design received the red dot design award 2008 which, according to the Design Zentrum Nordrhein Westfalen, is based on criteria such as innovation, functionality, quality and ergonomics.
The 108 light-emitting diodes of the Polaris (700 model) distribute light with a color temperature of 4,600 Kelvin. "Cold light" (without long-wave infrared content) is generated by means of a phosphor layer on the semiconductor and focused via an optical system. The LEDs are installed in the reflectors in pairs.
The individual light paths form a light cylinder which has an illumination depth of about 1,100 millimeters and a variable diameter of 220 to 290 millimeters. This ensures that the light of each LED can be focused on the OR field and that several surgeons can work simultaneously on the OR field without noticeably reducing the brightness.
Press release: Precision lighting with the new Dräger Polaris...
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Monday, November 16, 2009
DuraSeal Spine Sealant Gets FDA Green Light
Covidien has made an announcement that it obtained FDA approval for the DuraSeal™ Spine Sealant, a synthetic hydrogel indicated for closure of dural tears that occur during spine surgeries. According to MassDevice, it took seven years and a $245 million merger of Covidien with Confluent Surgical to deliver DuraSeal to the market.
From the press release:
In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100% of the time, compared with 64% of the time by the control group. The safety results between the two groups were similar, given the patients' medical conditions and the nature of the complex spinal procedures performed.The new sealant is a 100% synthetic hydrogel that provides excellent tissue adherence, is absorbed by the body and is easy to apply. Stored at room temperature, DuraSeal spine sealant takes only two minutes to prepare and three seconds to set, which enables surgeons to achieve an intra-operative dural seal quickly.
Press release: Covidien Introduces First FDA-Approved Spine Sealant ...
Product page: DuraSeal ...
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Friday, November 13, 2009
Conserve Plus Hip Resurfacing Wins OK in US
Wright Medical received clearance from the FDA to bring to market the CONSERVE® Plus Total Hip Resurfacing System. Particularly appealing to younger, active patients, the Conserve Plus is designed as a potential alternative to traditional total hip replacement with the goal of saving as much bone tissue as possible.
The approval permits Wright to market CONSERVE® Plus in the original femoral and acetabular component configuration specified in its PreMarket Approval (PMA) application and enables the Company to initiate efforts to introduce additional enhancements to the system which are currently only available outside of the United States.The CONSERVE® Plus system is designed to offer pain relief and restoration of function while retaining as much healthy bone as possible and preserving future surgery options, including a primary total hip replacement.
The approval follows a successful clinical trial involving more than 1,300 patients, including those enrolled under Continued Access protocols, providing patient data of CONSERVE® Plus clinical data in postoperative periods of up to eight years in length. Wright will commence surgeon training in the first phase of its U.S. introduction.
To date, the overall survivorship of CONSERVE® PLUS implants is 97%. Almost all the patients enrolled in the study have returned to their active lifestyles without pain.
Press release: Wright Medical Group, Inc. Receives FDA Approval to Market CONSERVE(R) Plus Total Hip Resurfacing System...
Product page: CONSERVE Plus Total Hip Resurfacing System...
Flashbacks: Birmingham Hip, or How to Sell Fresh Hips to Boomers ; iUni Resurfacing Knee Approved in US, Now Goes to Europe; Cormet™ Hip Resurfacing System; Personalized Bicompartmental Knee Resurfacing System from ConforMIS Gets CE Mark
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Thursday, November 5, 2009
Freedom Leg Replaces Crutches for Easier Mobility
Everyone hates having to use crutches after a leg injury, so a company that started as a bicycle manufacturer and recently evolved into medical mobility products thinks it's got the answer. The Freedom Leg from Forward Mobility out of Edmonds, Washington transfers the weight of the body to the upper leg, completely relieving the injured area from strain. Made out of composite materials, the device has a weight of only 2.6 pounds (1.2 kilo).
Go beyond the limitations of crutches, wheelchairs or scooters. It is truly an off-loading prosthetic that allows the user to fully integrate the device into their lives, giving them complete mobility. The user has the ability to accomplish all their normal day to day tasks without assistance, while at the same time keeping the strength in upper muscles of the injured leg.
Product page: Freedom Leg...
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Tuesday, November 3, 2009
Simple iPhone App Measures Spine Angles on X-rays
Dr. Frederic P Jacquot, an orthopedic surgeon from France, developed an innovative iPhone application that could measure spine curvature angles "on the fly." Just like other spine clinicians, Dr. Jacquot was trained to measure the Cobb angle, kyphosis angle, and the sacral slope on spine radiographs. So instead of using a protractor, he realized that he could utilize the accelerometer inside the iPhone to do it.
All that one has to do in using the device is align the side of the iPhone to the standard tracings we use routinely, and the position sensor built in the iPhone will do the rest.The precision of the device itself is 1/10th of a degree, far more precise than the precision of the measure as determined in everyday practice and the literature.
Measures are logged for further use and may be sent by e-mail to the surgeon or staff for recording purposes, with the levels of the measured curve, type of curve and patient id or number. A calibration procedure was also implemented to accurately measure the angle with the horizontal plane as in the sacral slope.
Product page: CobbMeter ...
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Wednesday, October 21, 2009
ThumBlade Scalpel Safety System
Here's an interesting new take on improving the safety for scrub techs, nurses and surgeons. ThumBlade™ scalpel system from Precision Medical Devices Inc. (Marlboro, NJ) is a no contact, disposable safety sheath that covers blades, and allows activation of the scalpel with just one hand. So no more sharps and no more mosquito use to mount a blade.
Medgadget has obtained the following details about the device:
Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.
Product page: ThumBlade™ safety scalpel system...
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Tuesday, October 20, 2009
Single Chip Stereo Endoscopy from Visionsense Coming to an OR Near You
Visionsense out of Orangeburg, New York, a company that makes single chip 3D endoscopic vision technology, has raised $8M in VC funds to begin full scale marketing of its unique technology in the US and Europe. The firm's Visionsense Stereoscopic Vision System, designed to improve depth perception and understanding of complex surgical anatomy, can be used for a variety of complex surgeries, such as skull-base and keyhole neurosurgical cases, as well as a wide range of laparoscopic procedures.
Camera Control Unit (CCU) – The CCU consists of a single Pentium PC with proprietary Visionsense hardware and software.
3D Stereoscopic Display - The CCU connects to a stereoscopic display with flexible arm for multiple viewing angles (requires glasses).
Video Cart - specifically designed to maximize surgeon ergonomics and minimize the footprint in the operating room. The VSII is designed to work with:
Cameras - The VSII uses various configurations of cameras specifically designed for transnasal and keyhole neurosurgical applications. Currently, there are 2 lengths (170mm and 300mm) and 2 angles (0 and 30 degree). The cameras are able to be sterilized and are reusable for 40 procedures.
LED Light Source - The VSII uses its own customized light source which uses a few watts of power to illuminate the surgical field.
Digital Recording/playing/editing procedures, in both mono and stereo
Product page: VSII -Visionsense Stereoscopic Vision System
Flashback: Single Chip Stereo Endoscopy from Visionsense
(hat tip: Globes)
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New Generation of Splint Designs from Exos
When it comes to broken bones and torn cartilages, today's orthopedic splints and casts are full of disadvantages that Exos Corporation is trying to overcome with its product line. Waterproof, breathable, and adjustable, Exos braces should be perfect for dedicated athletes and active people that don't want to be held back by an injury. Couple that with an attractive look that's not begging for a friend's autograph, and you're good to go out in style with your compound fracture.
The technology consists of three layers of high tech polymers and foam that when laminated together create a lightweight matrix with features that have multiple benefits for practitioners and their patients. Exos products feature easy to use, clean, waterless application that do not require water, stockinette or cotton padding for application. They are simple to remove and do not necessitate the use of messy, loud, often disturbing cast saws. Exos products provide excellent stabilization with superior comfort for greater patient compliance.
Link: Exos Corp...
(hat tip: Gizmodo)
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Tuesday, October 13, 2009
Cook Releases Biologic Graft Info Site CookBiodesign.com
Cook Medical has been trying to educate physicians about company's biologic grafts in order to spur wider adoption of these innovative materials for various surgical applications. To that end, this week at the 2009 Clinical Congress of the American College of Surgeons in Chicago, Cook is unveiling a new website, CookBiodesign.com, which is essentially a library for just about everything you'd want to learn about the firm's biologics. From videos and animations demonstrating the use of the grafts, to datasheets on individual products, as well as links to relevant abstracts at PubMed, the site aims to answer any questions on how to select and use of these relatively new surgical materials.
Link: CookBiodesign.com...
Flashbacks: Cook Medical's Biodesign Hernia Graft; Cook Medical's Biologic Mesh Looks Good in Study
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Wednesday, September 16, 2009
Medtronic Releases New Intraop Nerve Integrity Monitors
Medtronic has just announced the availability of a couple new intraoperative nerve integrity monitors, primarily for neurosurgeons and arthopods. The NIM-Response® 3.0 and NIM-Neuro® 3.0 help locate critical nerves during surgery and monitor their integrity throughout the procedure. The devices should help prevent nerve damage during surgeries and lead to easier repairs with less fear of damaging fragile nerve tissue.
During minimally invasive or traditional open surgery, Medtronic’s Nerve Integrity Monitor (NIM®) systems enable surgeons to identify and confirm motor nerve function and monitor major motor nerves throughout the body, such as cranial nerves in a patient’s head, face and neck. If there is a change in nerve function, the NIM system provides visual and audible warnings to alert the surgeon and operating room staff. This helps reduce the risk of nerve damage during surgery, improving safety and peace-of-mind for patients and surgeons.The NIM 3.0 systems are the first and only nerve monitors in the marketplace that fully enable:
* Simultaneous monitoring during bipolar cautery
* Artifact detection software that distinguishes artifacts (false signals) from true nerve signals
* Stim Bur technology that combines stimulation with Medtronic’s electric Visao® High-Speed Otologic Drill
* Real-time continuous monitoring of nerve function via APS™ (Automatic Periodic Stimulation)* that provides early warning of a change in nerve functionWith completely redesigned software, the new NIM 3.0 systems are easier to use and more convenient for the operating room than prior models. Users can navigate easily and quickly between three simple modes: Setup, Monitoring and Reports, and use default or custom settings. In addition, the new systems include multiple reporting options that can be easily saved for patient records.
The NIM-Response 3.0 monitors up to four channels of nerve-muscle combinations at a time and is frequently used in skull-based and head and neck procedures. With the NIM-Neuro 3.0, neurotologists and neurosurgeons can monitor up to eight channels of nerve-muscle combinations during complex and delicate surgeries, such as glomus tumor removals. In the future, Medtronic expects a new microscope overlay for the NIM-Neuro 3.0 will help bring monitoring within the surgical field by importing the NIM signal through a high-end microscope as the surgeon operates.
Press release: Medtronic Launches New and Innovative Intraoperative Nerve Integrity Monitors for Surgeons
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Thursday, July 30, 2009
ArthroSteer Steerable Arthroscopy Product Line Announced
Orthodynamix has announced the availability of their ArthroSteer steerable arthroscopy instrument line. During arthroscopy, it is often difficult to get your instruments exactly where one wants them to go because of the tight spaces involved. It is these challenges that Orthodynamix hopes to make less stressful on the surgeon and more effective for the patient.
The tip of the instrument can move 180 degrees side-to-side, and can rotate 360 degrees. What makes these tools unique, however, is that the tip and the bendable spine rotate independently, which allows more precise control and gets the tip exactly where it is supposed to be.
Here's more info from Orthodynamix:
These instruments incorporate a flexible spine which is controlled via the instrument’s thumb wheel. This thumb wheel allows intuitive spine flexation incorporated with a mechanism that locks the spine in its desired bend. The surgeon controls the bend of the instrument’s spine up to 180 degrees, in one plane, to which the jaw or tip is attached. Further controlling the jaw’s or tip’s orientation in the joint capsule is developed by the capability of rotating them along their axis 360 degrees via a finger wheel. The surgeon controls the jaw’s opening and closing via the handle’s trigger.Another compelling technology aspect of the punch is that there is sufficient jaw force (approximately 70 lbs) transmitted by the trigger, even with the spine flexed, enabling the surgeon to easily cut through labrum tissue. Moreover, this jaw force is controlled by a unique compression spring preventing the surgeon from applying excess force to the jaw resulting in a possible failure. The trigger will breakaway during higher than required punching force (greater than 75lbs). But, the trigger will set back for continued use.
Currently only the punch and grasper are available, but the coagulator and ablator are soon to be released.
Read the press release here...
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Tuesday, July 14, 2009
Personalized Bicompartmental Knee Resurfacing System from ConforMIS Gets CE Mark
ConforMIS(Burlington, MA) has announced that the company won European approval for the iDue bicompartmental knee resurfacing implant and iJig instrumentation, both custom designed to fit and work together. This is the only custom made bicompartmental knee resurfacing system currently available on the market, as we have reported before. For our previous coverage of this technology, see flashbacks below.
The iDuo is the first and only patient-specific, bicompartmental resurfacing implant on the market. It is designed for patients whose arthritic damage is limited to either the medial or lateral compartment of the knee, in addition to the patellofemoral compartment. Each iDuo is custom designed and manufactured from an individual patient's CT scan using ConforMIS' patented iFit® technology, allowing for an entirely personalized fit.The iDuo resurfaces only the affected areas, preserving far more bone than a traditional knee replacement surgery. The iDuo also preserves the anterior and posterior cruciate ligaments, which helps to maintain natural knee kinematics. The extent of tissue and bone conservation with the iDuo helps patients retain their future surgical options.
The iDuo surgical procedure utilizes patient-specific instrumentation called iJigs that are designed from the same imaging data as the implant. The iJig cutting a nd placement guides eliminate manual sizing during surgery and provide tactile guidance to precisely place the implant, significantly reducing the number of bone cuts required for the surgery, simplifying the steps, and increasing the reproducibility of surgical results.
Features from the product page:
Available for the patellofemoral and medial or lateral compartments
Preserves bone and cartilage in unaffected compartments and future surgical options
Preserves anterior and posterior cruciate ligaments, helping to maintain knee kinematics
Precise, anatomic fit to ensure ROM without impingement or overhang
Complete cortical rim coverage to reduce risk of tibial implant subsidence and loosening
Disposable, patient-specific iJig instrumentation with built-in image guidance
Simple, reproducible surgical technique
Potential for less post-operative pain and shorter post-operative recovery time
Press release: ConforMIS Receives CE Mark for the First and Only Personalized Bicompartmental Knee Resurfacing System...
Product pages: iDuo™ Bicompartmental Knee Resurfacing Device; iJig™ Pre-Navigated Instrumentation
Flashbacks: iUni Resurfacing Knee Approved in US, Now Goes to Europe; Personalized Bicompartmental Knee Implants from ConforMIS Go On Sale).
Video below the fold showing how the system functions:
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Wednesday, July 8, 2009
New Device Aims to Measure Hand Muscles Strength
A team of bioengineering students from Rice University developed a device to measure the strength of intrinsic hand muscles (thenar, hypothenar, interosseus and lumbrical muscles). The Peg Restrained Intrinsic Muscle Evaluator, or PRIME, was created to replace the common test where the patient pulls and pushes at the doctor's hands and fingers. The real goal is to quantify finger/muscle strength for a more accurate diagnosis for carpal tunnel syndrome evaluation and other disorders.
Rice University reports:
The device has three elements: a pegboard restraint, a force transducer enclosure and a PDA custom-programmed to capture measurements.In a five-minute test, a doctor uses pegs to isolate a patient's individual fingers. "You wouldn't think it works as well as it does, but once you are pegged in, you can't move anything but the finger we want you to," Miller said.
A loop is fitted around the finger, and when the patient moves it, the amount of force generated is measured. "PRIME gets the peak force," Xu said. "Then the doctor can create a patient-specific file with all your information, time-stamped, and record every single measurement." PRIME integrates with existing systems in a manner compliant with the Health Information Portability and Accountability Act, better known as HIPAA, he said.
Xu hopes it will help hospitals and rehabilitation clinics compare the effectiveness of surgical interventions and diagnose neuromuscular degenerative diseases.
Press release: Rice University team's award-winning device could benefit treatment of hand injuries...
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Tuesday, June 16, 2009
PK100 PowerKnee to Help Bad Legs Walk Again
Tibion Bionic Technologies out of Moffett Field, California 
has developed a powered knee orthosis to help people with all kinds of neuromuscular or joint disorders, such as status post lower extremity surgery, chronic weakness of leg muscles, osteoarthritis, or even strokes, to get off the crutches. The device is powered by an internal battery and controlled by an algorithm that aims to make the power assist automatic and unnoticeable to the patient. The Engineer Online is reporting that UCSF is currently testing the PK100 on a select group of patients:
The so-called Tibion PK100, or PowerKnee, is a robotic boot that inserts into the user's shoe and extends up to mid-thigh. It is equipped with multiple sensors and microprocessors that can detect the user's actions - such as making a transition from sitting to standing, or climbing stairs - and adjust its support accordingly.Jean Nelson, vice-president of marketing of Tibion, the maker of the PowerKnee, based at NASA Research Park in Moffett Field, said: 'Basically, the device determines what the patient is trying to do and then assists in that action. The computer's learning algorithm allows it to adapt after the first few steps.'
And here are additional details about the device taken from Tibion's product page:
Utilizing sensors throughout the device and in a shoe insert, Tibion’s PK100 detects the user’s actions, such as sitting/standing, walking and ascending/descending stairs. Microprocessors on the device analyze this information and transparently apply the force needed to augment the user’s actions. The result is appropriately applied external forces that supplement muscle strength during critical daily activities.Features of Tibion’s PK100:
• Non-invasive
• Portable
• Battery-operated
• Transparent activation
• Easily adjustable for multiple patients
• Customizable settings with stored profiles
Watch the PowerKnee in action:
Device brochure: Tibion PK100
(hat tip: The Engineer Online)
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Wednesday, June 10, 2009
Orthovita Brings Competition to Injectable Bone Cement Market
Polymethylmethacrylate (PMMA) plastic has been a standard cement substance used by orthopedic surgeons to inject into bone for repair of fractures or stabilization of impants. Now Orthovita, a company out of Malvern, Pennsylvania, has received FDA approval for a new substance that plans to give PMMA a run for its money. The CORTOSS bone augmentation material recently completed a clinical trial testing its effectiveness and safety for vertebral compression fractures, producing rather positive results.
CORTOSS Bone Augmentation Material is a blend of cross-linking resins and reinforcing fillers, which include the proprietary bioactive glass found in Orthovita's VITOSS™ Bioactive FOAM products. Unlike PMMA, CORTOSS does not contain a methylmethacrylate monomer. The composite has a constant, paste-like consistency when being injected and sets quickly to create a load bearing implant with the mechanical properties of human cortical bone. In the pivotal study, CORTOSS demonstrated flow and fill into the existing intra-vertebral anatomy rather than displacing it like PMMA, which may reduce the volume of material required for clinical success. Pre-clinical in vitro and in vivo studies show that, after implantation, a bioactive response occurs at the implant's surface which promotes the deposition of calcium phosphate, thereby strengthening the implant-bone interface. The unique flow characteristics of CORTOSS allow low-pressure, manual delivery through Orthovita's ALIQUOT™ Delivery System. CORTOSS' mix-on-demand preparation allows clinicians to stop material injection for an indeterminate amount of time, thus providing a high degree of procedural flexibility.In April 2009, Orthovita submitted the 2-year follow-up clinical data for patients enrolled in the company’s prospective, randomized, multi-center study comparing the efficacy of PMMA to CORTOSS. In this 256-patient pivotal trial conducted under an investigational device exemption, CORTOSS achieved its primary end-point of non-inferiority to the PMMA control at 24-months using a composite endpoint success rate reflecting improvement in the Visual Analogue Pain Scale (VAS) pain score, maintenance or improvement in Oswestry Disability Index (ODI) function assessment, maintenance of vertebral height and alignment, and no subsequent device-related surgical intervention at the index treatment level. In the pivotal study at 24 months:
• The composite endpoint success rate was 76.9% for patients treated with CORTOSS and 73.4% for PMMA patients.
• With an ODI success rate of 96.7%, the CORTOSS patient group experienced a statistically significant benefit in function success over the PMMA group, which had an ODI success rate of 88.4%.
Early patient outcomes were also assessed in the pivotal study at 3 months:
• The composite endpoint success rate was 82.8% for patients treated with CORTOSS and 73.7% for PMMA patients.
• With a VAS success rate of 86.6%, the CORTOSS patient group experienced a statistically significant benefit in pain success over the PMMA group, which had a VAS success rate of 75.0%.In addition to the statistically significant benefit in pain success at three months and function success at 24 months, the CORTOSS population experienced measurable benefits over the PMMA cohort in the following outcomes:
-A 43.4% reduction in subsequent, adjacent level fractures in CORTOSS patients treated for a primary fracture at one level, as measured at the end of the 24-month follow-up period.
-The CORTOSS patients required an average of 30% less material to achieve fracture fill.
Product page: Cortoss Bone Augmentation Material
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Tuesday, June 2, 2009
BRYAN Cervical Disc Gets FDA Approval
BRYAN® Cervical Disc, a product of Medtronic Sofamor Danek we first profiled back in 2007, has now been approved by the FDA. The implant, composed of a polyurethane and titanium discs designed to fit between adjacent vertebral bodies in the neck, is indicated "in skeletally mature patients for reconstruction of the disc from C3-C7 following single-level discectomy for intractable radiculopathy and/or myelopathy," according to the FDA.
From the FDA info page on the product:
How does it work? Once the diseased disc is removed, the BRYAN® Cervical Disc is placed in milled pockets in the adjacent vertebral bodies. The device consists of two main metal pieces separated by a polyurethane part.When is it used? The BRYAN® Cervical Disc is intended to be used to replace a cervical disc from C3-C7 following removal of the disc for intractable radiculopathy and/or myelopathy (conditions that result from a diseased or bulging disc). The patient should have failed at least 6 weeks of conservative therapy before receiving this device.
What will it accomplish? The device should help stabilize the operated spinal level. Unlike a fusion procedure, the BRYAN® Cervical Disc is designed to allow motion at the operated spinal level. The effects of the diseased disc removal should include pain relief and improved function.When should it not be used? The BRYAN® Cervical Disc should not be implanted in patients with the following conditions:
* Active systemic infection or infection at the operating site;
* Allergy to titanium, polyurethane, or ethylene oxide residues;
* Osteoporosis defined as a DEXA bone mineral density T-score equal to or worse than -2.5;
* Moderate to advanced spondylosis characterized by bridging osteophytes, marked reduction or absence of motion, or collapse of the intervertebral disc space of greater than 50% of its normal height;
* Marked cervical instability on radiographs (e.g., radiographic signs of subluxation greater than 3.5 mm or angulation of the disc space more than 11 degrees greater than adjacent segments);
* Significant cervical anatomical deformity or compromised vertebral bodies at the index level (e.g., ankylosing spondylitis, rheumatoid arthritis, or compromise due to current or past trauma);
* Significant kyphotic deformity or significant reversal of lordosis; or
* Symptoms necessitating surgical treatment at more than one cervical level.
FDA approval : BRYAN® Cervical Disc - P060023...; Approval Order (.pdf); Summary (.pdf); Labeling (.pdf)
Flashbacks : Medtronic's Bryan® Cervical Disc System; Medtronic's Cervical Discs Deliver Good News to the Company
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Siemens Introduces Cappa C-Nav System for Navigating the Body Without Radiation
At the upcoming Congress of the European Federation of National Associations of Orthopaedics and Traumatology (EFORT), to be held June 3 - 6, 2009 in Vienna, Siemens is planning to unveil a new navigation system for orthopedic and neurological surgeons called Cappa C-Nav. We think this technology can potentially improve outcomes and increase precision for a number of open and percutaneous procedures, such as spinal fusions and hip screws.
Siemens describes its technology:
For surgical interventions, physicians increasingly use modern navigation technologies comparable. With Cappa C-Nav, Siemens Healthcare offers an optical navigation system that is especially suitable for spinal as well as trauma surgery. The new navigation system enables surgeons to perform interventions with greater safety and precision. Additionally, the method also minimizes radiation exposure to the patient as well as the OR staff.
The development of new technologies is propelled forward by the increasing trend toward minimally-invasive operations. Siemens’ years of medical engineering expertise in the OR arena follows this trend and is now offering intra-operative imaging and optical navigation technology. Especially orthopedics and trauma surgeons will benefit from this innovative idea.Precision is a substantial pre-condition in the OR in general, but in particular in spinal and trauma surgery as well as in orthopedics. In spinal surgery for example the new method helps to accurately position pedicle screws in the spine; in orthopedics navigation technology is used to support online visualization during stabilization of degenerated bones. Prior to the operation, the surgeon creates a 3D X-ray data set of the region of interest. This data set is used like a map for orientation during surgical intervention. The surgeon navigates during the operation by using so-called optical tracking via a special stereo camera. The surgeon is able to use the navigation system easily and by himself via a sterile user interface. The surgeon’s instruments and patient’s body region of interest are provided with differently arranged small reflecting marker spheres. The camera continuously acquires the position of these spheres and informs the navigation system of their location. This enables the surgeon to proceed with even greater accuracy during the operation by virtually testing the length of the screws, for example. Also the ability to continuously check the progress and results of an operation may save patients the need for a second surgical intervention.
Cappa C-Nav is optimally tailored for the mobile C-arm Arcadis Orbic 3D and, if needed, can be retrofitted for these systems.
Press release: The optical navigation system Cappa C-Nav facilitates minimally-invasive surgical procedures... (.pdf)
Flashbacks: iGuide CAPPA Knows Where the Tip of the Needle Is
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Monday, June 1, 2009
New Total Ankle Replacement Receives FDA Approval
The Food and Drug Administration has announced approval of the Scandinavian Total Ankle Replacement (STAR) system from Small Bone Innovations, Inc. This implantable total ankle replacement system is intended for use in patients where there is severe arthritis or other deformities that hinder the range of motion of the joint.
Small Bone Innovations claims that this design of the STAR system is the first of its kind because it relies on movable bearings that glide across the surface of polyethylene. The advantage is that this still affords some joint movement as opposed to traditional fusion surgeries that join the tibia to the talus bone for additional strength but severely limit motion.
“This device offers another treatment alternative to fusion surgery, and more closely imitates the function of a natural ankle,” said Daniel G. Schultz, M.D., director of the FDA’s Center for Devices and Radiological Health. “For the first time in the United States, a patient may retain some ankle mobility with this non-constrained, mobile-bearing device.”
Press release : FDA Approves New Total Ankle Replacement System
Company profile : Small Bone Innovations, Inc.
Flashback : Non-Metal Ankle Replacement Available at UCSD
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Friday, May 22, 2009
First Pyrocarbon Shoulder Arthroplasty Performed in Human
Tornier Inc. (Edina, MN) has just announced that the first implant of a shoulder arthroplasty comprised of pyrocarbon occured in France. This is not the first time we have covered the use of pyrocarbon, or pyrolytic carbon as it is commonly referred to, in medical devices, but it is a new application.
Pyrocarbon, developed as nuclear fuel cladding by General Atomics, has a structure similar to graphite, but with slightly different atomic bonding such that it gives it better durability in comparison to graphite. It has the advantage as an implantable biomaterial because it does not provoke blood clotting and can easily be made into geometries that mimic the natural elements that are being replacing. In terms of support and wear, the advantage of pyrocarbon is the elastic modulus, or its ability to deform when force is applied. Too hard, like in the case of ceramics, and this will cause an undue stress load on the natural bone, which can lead to premature aging and fracturing. Too soft, like in the case of polyethylene, and this can lead to deformation of the implant, excessive wear, the need for multiple replacements, and inflammation if wear particle break off from the implant. Pyrocarbon has an elastic modulus within the same region as that of bone which provides for a more natural fit. This is illustrated in the following force load diagram.
Tornier has a ten year history of pyrocarbon carpometacarpal implants for the base of the thumb, various interpositional implants for the wrist, and radial head implants for the elbow. The arthroplasty shoulder implant is a natural progression of pyrocarbon's orthopedic device development.
Press release: Tornier Announces First Human Implant of Pyrocarbon Shoulder Arthroplasty Prosthesis...
Company site: Tournier
Flashback: Pyrolytic Carbon: Now and Then...
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» Digital Subtraction Angiography on a Single Image (May 14, 2009)
» BrainLab's Digital Lightbox Getting an Upgrade (May 13, 2009)
» Occipitocervical Fusion Module from Medtronic (May 8, 2009)
» PEEK PREVAIL Cervical Interbody Device for Spinal Fusions (May 5, 2009)
» Arthro Sim insightArthroVR Gets Upgrade (May 5, 2009)
» Magnus Operating Table from Maquet (May 4, 2009)
» Injectable Bone Graft for Minimally Invasive Spinal Surgery (April 30, 2009)
» Move On, Ilizarov: A New Magnetic Stretching System May Lead to Safer Bone Lengthening (April 16, 2009)
» Barricaid Anular Reconstruction Device Gets EU OK (April 14, 2009)
» Latest Update on DoD, DARPA, and Dean Kamen's Prostheses (April 14, 2009)
» MORPHO Cooling Packs Stay Cold for Hours (April 6, 2009)
» Demasq Offers Soft Tissue Analysis from X-rays (April 3, 2009)
» EU OK's IlluminOss Photodynamic Bone Stabilization System (March 26, 2009)
» Cardinal's Endura Scrubs for the Modern Clinician (March 19, 2009)
» Silk Material to Replace Cartilage in Ortho Surgeries (March 12, 2009)
» Genesis IPG Now for Chronic Angina (March 11, 2009)
» New Negative Pressure Wound Care Device from Smith & Nephew (February 25, 2009)
» MAKO Introduces RIO Robotic Arm for Orthopedic Surgeries (February 24, 2009)
» Light Used to Harden Injectable Bone Compound in First Clinical Case (February 20, 2009)
» New Bone Growth Peptide Developed (February 20, 2009)
» Spinal Implants with CleanFUZE Silver Ion Antibacterial Technology (February 17, 2009)
» New Bone Cement to Prevent Dangerous Battle Injury Infections (January 29, 2009)
» TrEndo Tracking System Helps Surgeons Practice, Evaluate Technique (January 20, 2009)
» Computers to Help with Hip Replacements (January 7, 2009)
» Amimon's High Definition Wireless Video Goes Clinical (January 5, 2009)
» Image Guided Spine Navigation Systems Improve Spine Surgeon's Screw Placement (December 15, 2008)
» SmartBolts Help Avoid Tightening Errors (December 5, 2008)
» Shaped Titanium Implants Help Bone Growth for Better Grip (December 4, 2008)
» TruSystem 7500: New OR Table from TRUMPF (November 21, 2008)
» Valeo Silicon Nitride Ceramic Spacers Get CE Mark (November 17, 2008)
» Mechanical Sensor Teams Up With Ultrasound for Bone Monitoring (November 12, 2008)
» Game Ready Hand Wrap for Rapid Rehab (November 10, 2008)
» New Knee Replacement System, Align 360, Gets FDA OK (October 30, 2008)
» PlasmaBlade Finds New Uses With New Attachments (October 29, 2008)
» OsDx Stratifies Old Hips Before They Break (October 28, 2008)
» Vertebral Crush Fractures...Balloons, Cement and More (October 17, 2008)
» Wellex Interspinous Process Medical Device Wins CE Mark (October 10, 2008)
» ChonDux Aids in Operative Cartilage Repair (October 6, 2008)
» Stuck in a Cast? MyoSpare Wants to Exercise Your Unused Muscles (September 30, 2008)
» Eon Mini, World's Smallest Spinal Cord Stimulator, Makes Clinical Debut (September 17, 2008)
» Digital Lightbox Brings Minority Report to The OR (No Precognition Capabilities) (August 19, 2008)
» Long Lasting Spinal Cord Neurostimulator from St. Jude Gains Approvals (August 13, 2008)
» Physio-L Lumbar Artificial Elastomeric Disc Gets EU OK (August 7, 2008)
» Personalized Bicompartmental Knee Implants from ConforMIS Go On Sale (August 5, 2008)
» Hydrogel as a Repair Device for Torn Cartilages (August 4, 2008)
» TriboFit Hip System Features Microelastohydrodynamic Lubrication (no more, no less!) (July 30, 2008)
» Force-feedback Offerings from Haption (July 28, 2008)
» PlasmaBlade System Gets FDA Go Ahead (July 24, 2008)
» SlimFuse Cervical Plate Goes On Sale (July 24, 2008)
» CombiCarrier II Wins Silver for Good Design (July 18, 2008)
» Metal Layering Technique Leads to Fine Tuned Implants (July 3, 2008)
» Non-Metal Ankle Replacement Available at UCSD (June 24, 2008)
» DARPA Wants Silly Putty for Serious Situations (June 18, 2008)
» LDR Receives 510(k) for Spinal Transforaminal Approach Implant (May 29, 2008)
» SpineAssist Gets New FDA Approval (May 28, 2008)
» The Third Install in the US of Aquilion ONE CT from Toshiba (May 21, 2008)
» Demand Is High for Brilliance iCT, a 256-Slice CT from Philips (May 19, 2008)
» Peak PlasmaBlade Wants to Be The New Bovie (May 7, 2008)
» Gore Receives EU's CE Mark for PRECLUDE Vessel Guard (May 7, 2008)
» Fluidhand: Prototype Prosthetic Device (April 29, 2008)
» OrthoSim, an Orthopedic Implant Simulator (April 25, 2008)
» World's Smallest Spinal Cord Stimulator Approved in US, Europe (April 14, 2008)
» Scientists Describe New Method for Modeling Strain (March 19, 2008)
» Spinal Non-fusion Technology from Raymedica (March 17, 2008)
» Canada OK's Oxiplex® Gel Adhesion Barrier for Spine Surgery (March 5, 2008)
» ActiveCare+SFT®: A Breath Synchronized DVT Prevention (March 3, 2008)
» iUni Resurfacing Knee Approved in US, Now Goes to Europe (February 26, 2008)
» Eon Promises Longer Lasting Neurostimulation (February 14, 2008)
» Technology Offers Glimpse of Early Osteoarthritis, DJD (February 12, 2008)
» Acrobot Surgical Robot Makes Students as Good as Surgeons (February 11, 2008)
» ReeTrakt Surgical Retractor (January 15, 2008)
» Biomechanical Analysis Interface from Organic Motion (January 8, 2008)
» Somatom Definition AS: The World's First Adaptive Computed Tomograph (December 6, 2007)
» AquilionONE CT from Toshiba Cleared by FDA (November 27, 2007)
» FusionOptic™ Technology from Leica (November 16, 2007)
» Non-Contact 3D Med Display (November 7, 2007)
» Magnetom Essenza Aims for the Lowe$t Common Denominator (October 24, 2007)
» Sony's Versatile HD Med Monitor (October 5, 2007)
» X-STOP® IPD® Procedure (September 28, 2007)
» Warm Ice for Gadgets in the (Polycrystalline) Diamond Age (September 19, 2007)
» Nano-dized Titanium Spurs Faster Bone Growth (September 19, 2007)
» Position Sensors to Minimize Spinal Cord Injuries (September 17, 2007)
» Signa HDe 1.5T MR Diagnostic Imaging System (August 22, 2007)
» S&N Hip Replacement Recall (August 16, 2007)
» Hip Pads vs Hip Fractures (August 9, 2007)
» Spine Wave Stands Tall (August 9, 2007)
» Probing Artificial Joints with Sound (August 3, 2007)
» The Acrobot® Surgical System Gets Infusion of Capital (August 1, 2007)
» PowerFoot One: Active Ankle-foot Prosthesis from MIT Unveiled (July 24, 2007)
» Medtronic's Cervical Discs Deliver Good News to the Company (July 18, 2007)
» 560 Series HD Camera from Smith & Nephew (June 21, 2007)
» Custom Fit Total Knee Replacement (June 5, 2007)
» Medtronic's Bryan® Cervical Disc System (May 25, 2007)
» The APOS System for Knee Osteoarthritis (May 7, 2007)
» StaXx® FX Structural Kyphoplasty System (April 18, 2007)
» World's First 'Spinal Transplant' Completed (March 26, 2007)
» Synthetic Scafold to Repair Damaged Knees (March 22, 2007)
» Pilot Study of Genesis® Neurostimulation System in Angina (February 28, 2007)
» Cormet™ Hip Resurfacing System (February 23, 2007)
» Integra Life Sciences Launches TenoGlide™ Tendon Protector (February 14, 2007)
» The Navitracker™ (February 8, 2007)
» Woven Cartilage (February 7, 2007)
» X-ray System to Show Moving Bones in 3-D (February 2, 2007)
» Birmingham Hip, or How to Sell Fresh Hips to Boomers (January 31, 2007)
» 3mensio™ Technology: Medical Visualization and Surgical Planning Software (January 26, 2007)
» 'Shape-memory' Polymers May Soon Aid Orthopedic Surgery (January 24, 2007)
» Take a Deep Breath: Adjustable Titanium Ribs Are Here (January 23, 2007)
» Seeing Cartilage, At Last (January 5, 2007)
» ActiveCare DVT®: Goes with Patient; Goes to Cleveland (December 27, 2006)
» SafeFlo® IVC Filter (December 18, 2006)
» Artificial Spinal Disc Shown Superior to Fusion (December 13, 2006)
» Dually Porous Glass Helps Damaged Bone Regenerate (December 7, 2006)
» UK Woman Has First 'Grow Your Own' Knee Transplant (November 28, 2006)
» Verté Seating Office Chair (November 22, 2006)
» Why Bone is Nearly Unbreakable (November 16, 2006)
» Wireless Sensors for Knee Replacements (November 9, 2006)
» In Australia, The Bones Grow You! (November 7, 2006)
» EN-TACT™: Emergency Noninvasive Tissue and Compartment Testing (October 26, 2006)
» "Nano" Hip Chip to Monitor Healing (October 23, 2006)
» OrthoGlide™ for Knees (October 16, 2006)
» MPH® Hemostatic Technology (October 3, 2006)
» PRESTIGE® Cervical Disc System (September 21, 2006)
» The AIC Hip Buffer™ (September 21, 2006)
» Portable Device to Monitor Tiny 'Earthquakes' of Stress Fractures (September 13, 2006)
» Custom-Built Body Parts: Little Shop of Horrors? (August 30, 2006)
» Live Surface, A Software for Surgeons (August 2, 2006)
» Spinal Fusion vs. Disc Replacement: To Fuse or Not to Fuse (August 2, 2006)
» The Only Bone Stimulator to Heal Fresh Fractures Faster (July 24, 2006)
» FDA Approves Clinical Trial for DIAM Spinal Stabilization System (July 11, 2006)
» O-arm™ Imaging System (July 10, 2006)
» Nanotech Surfaces for Ortho Implants (July 10, 2006)
» Technology to Directly Attach Artificial Limbs (July 5, 2006)
» Pyrolytic Carbon: Now and Then (May 22, 2006)
» The Gender Solutions™ High-Flex Knee (May 11, 2006)
» Eon™ Rechargeable Neurostimulation System (May 8, 2006)
» The SpineJet, A Water Scalpel (May 1, 2006)
» I-space Medical Imaging (April 25, 2006)
» Scan2Knit (April 19, 2006)
» Triathlon Total Knee Replacement Specifically for Women (March 17, 2006)
» Wireless C-Arms from Xograph (March 3, 2006)
» The Acrobot® Surgical System (February 9, 2006)
» FDA Approves Vidacare's First Pediatric Device (January 26, 2006)
» X-Ray Robot to Shadow Patient's Moves (January 25, 2006)
» Bidex: the Key to Vertebral Reconstruction (January 12, 2006)
» The Cyberhand (November 30, 2005)
» Fonar 360°™: A Room-Size MR Scanner (November 14, 2005)
» Predicting Fracture with Lasers (October 31, 2005)
» Electric Kenguru for the Disabled (October 13, 2005)
» First Human Implants of BioDisc™ (September 6, 2005)
» Chew on This: Mechanical Jaw Under Construction (August 5, 2005)
» Machines, software model helping to create better spinal implants (July 27, 2005)
» Fingernail Test for Osteoporosis (July 11, 2005)
» "Bionic Arm" Technology from the Rehabilitation Institute of Chicago (June 28, 2005)
» Robo-Legs (June 22, 2005)
» The SmartStep™ Gait System (June 21, 2005)
» SaluCartilage for Cartilage Defect Repair (June 2, 2005)
» Magnetic Targeting Device for IM Bone Implants (May 24, 2005)
» Shock Waves for Bone Growth (May 23, 2005)
» Mayo Clinic BC-10 MRI Coils (May 6, 2005)
» Adaptive Prosthetics (April 28, 2005)
» DARPA Encourages a Prosthetic Revolution (April 12, 2005)
» TraumaCad: a Surgical Planning by Orthocrat (April 4, 2005)
» Cervical-Stim® by Orthofix (March 28, 2005)
» The Scheker Prosthesis (March 22, 2005)
» TEM LX2 typeD (March 15, 2005)
» Cedara announces OrthoWorks and ImageSnap (February 21, 2005)
» 'Embracing the Artificial Limb' (February 18, 2005)
» SAM Pelvic Sling (February 4, 2005)
» Stratis ST ACL Reconstruction System (January 13, 2005)
» CyberLogic: Confronting Osteoporosis (January 6, 2005)
» Charite (December 24, 2004)
