Monday, November 17, 2008
Valeo Silicon Nitride Ceramic Spacers Get CE Mark
Amedica out of Salt Lake City, Utah won approval from European regulators to market the Valeo C and Valeo TL spinal intervertebral spacers made out of the firm's proprietary silicon nitride ceramic.
The Valeo family of ceramic spinal intervertebral spacers is intended to aid in surgical correction and stabilization of the thoracolumbar spine. These implants are designed to restore the biomechanical integrity of the anterior, middle and posterior spine, even in the absence of fusion, for a prolonged period of time. The Valeo family of spacers provides new functionalities compared to competing devices currently on the market and is believed to be the first family of silicon nitride ceramic implants available for spinal use in the world.“Amedica’s ceramic spinal spacers uniquely combine strength with an improved bone/implant interface and bone like imaging compatibility, making them a valuable alternative to currently available devices using conventional synthetic materials,” said Darrel Brodke, M.D., Professor and Vice-Chair, Director of Spine Service, Department of Orthopaedics, University of Utah School of Medicine. “Because these implants have a combination of distinguishing features, I would expect Amedica’s implants to be well received in Europe and Asia, where allograft bone is not frequently used.”
Product pages: Valeo C and Valeo TL
Press release: Amedica Receives CE MARK FOR THE WORLD'S FIRST FDA-CLEARED VALEO™ CERAMIC SPINAL IMPLANT SYSTEM...
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Wednesday, November 12, 2008
Mechanical Sensor Teams Up With Ultrasound for Bone Monitoring
Scientists at Empa, a Swiss research institute, have developed a mechanical pressure sensor that can be embedded within orthopedic implants, close to bone fractures, to provide physicians with post-operative status updates. The sensor features no electronics, and its results are read externally via ultrasound. According to Empa, the device is designed to monitor the healing process in broken bones as they grow back together.
From Empa:
The solution is in the form of a small, hollow spiral which sits on the implant together with a fluid reservoir. When the implant is subject to compression or tension the level of fluid in the spiral changes. This level is measured with the help of an ultrasonic device, and the resulting data allows the mechanical loading on the implant to be calculated. The ultrasonic image is, however, too indistinct to allow the fluid level to be determined visually, so the Empa researchers decided to analyze the ultrasonic signal in more detail. They quickly found a dependence between the ultrasonic echo generated over the complete spiral and the actual fill level – the weaker the ultrasonic echo measured, the higher the level, and therefore the greater the force acting on the sensor.The sensor produces reliable measurement data, as numerous experiments with artificial tissues – mixtures of gelling agent, glass ballotini and graphite powder, which depending on the mixing ratios allow different types of tissue to be simulated – have demonstrated. Not only that, it is also economic to manufacture, being very much cheaper than the existing electronic versions. The next step is to test the accuracy of the new method using various animal tissues, since each material has its own acoustic signature because it reflects and absorbs ultrasonic energy differently.
In addition, the Empa scientists are investigating the idea of making the sensor out of biodegradable materials, in which case the device would simply dissolve away in the patient’s body after completing its task. The surgeon need not therefore sharpen his scalpel a second time, there being no need to remove the sensor when the fracture has healed!
Press release: Monitoring broken bones without using electronics ...
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Monday, November 10, 2008
Game Ready Hand Wrap for Rapid Rehab
Game Ready, a company out of Alameda, California, that specializes in high tech anatomic wraps designed to deliver adjustable cold therapy coupled with pneumatic compressions, has introduced a novel device for post operative rehabilitation. The Hand Wrap, as the unit is called, will apply cooling to the wrist as well as controlled pressure to help with pain, to help promote healing, according to the company.
From the product page:
The Hand Wrap’s simple rectangular shape and adjustable straps mean you can use the Wrap flat against your entire hand or fold and bend the Wrap around a specific area. The Velcro®-style hook-and-loop closures adhere to Wrap sleeve for proper fit. Position Wrap on your hand in desired configuration, blue side facing in. Stretch the straps around hand and comfortably secure.Simply fill the Game Ready Control Unit with ice and water. Put the Hand Wrap on, connect it to the Control Unit, adjust the pressure, temperature, and timer settings, and press Start.
Press release: Game Ready(TM) Announces New Hand Treatment ...
Product page: GAME READY HAND WRAP ...
Product user manual (PDF)...
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Thursday, October 30, 2008
New Knee Replacement System, Align 360, Gets FDA OK
The FDA has given Cardo Medical of Los Angeles marketing approval for the firm's Align 360 Total Knee System, a device that the company says features a unique modular approach in implantation, done with common instruments familiar to surgeons:
John Kuczynski, Cardo Medical's Vice-President of Research and Development, commented, "The Align 360 Total Knee System is truly an advanced knee platform. Its femoral component features a funnel-shaped patella track that accommodates the quadriceps angle anatomy for both male and female patients, without the need for gender specific components which provides a tremendous inventory savings for all operating rooms. In addition, the anterior geometry of the femoral component has been designed to reduce antero-medial overhang of the femoral component, which has been clinically proven to be a cause of post-operative knee pain."
Dr. Andrew Brooks, Chairman and Chief Executive Officer of Cardo Medical stated, "We are pleased to have achieved this regulatory milestone and are excited to have rounded out our Align 360 platform. Our Total Knee System builds upon our Uni-compartmental and Patella-Femoral systems and is designed as a high performance treatment for tri-compartmental arthritis with choice of either a cruciate sparing or posterior stabilizing device. We now have a unique and comprehensive knee system which allows the surgeon to use matched instrumentation for surgical treatment of uni-compartmental, bi-compartmental and tri-compartmental arthritis. Our Align 360 platform boasts a common, modular instrument set and component design heritage and philosophy. Our novel, minimally invasive instrumentation is designed to enable surgeons to achieve superior surgical outcomes. Cardo Medical looks forward to introducing these and other orthopedic design innovations to the US market over the upcoming quarters."
To learn more about the system, head to this product page: Align 360 Total Knee System
Press release: Cardo Medical Announces FDA Clearance of the Align 360 Total Knee System
Align 360 Surgical Technique (.pdf)...
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Wednesday, October 29, 2008
PlasmaBlade Finds New Uses With New Attachments
PEAK Surgical, maker of the innovative PlasmaBlade replacement of the bovie, has put a couple extensions for its device onto the market.
The PlasmaBlade Needle, which has a fine needlepoint tip, is specifically designed for ultra-precise surgical procedures. The PlasmaBlade EXT is designed for use in surgical procedures requiring an extended-reach tip.In July, the U.S. Food and Drug Administration granted PEAK Surgical 510(k) clearance to market the PEAK® Surgery System, including the PlasmaBlade 4.0, for use in general surgery. The PlasmaBlade 4.0 is designed to be used to cut through all types of soft tissue, including skin, fat and muscle. All of the PlasmaBlade tissue dissection tools are used in conjunction with PEAK's PULSAR™Generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to create surgical incisions and control bleeding. They offer the exacting control of a scalpel and the coagulation of traditional electrosurgery without extensive collateral damage.
Press release: PEAK Surgical Introduces PlasmaBladeTM Product Line Extensions for Use in General Surgery
Flashbacks: PlasmaBlade System Gets FDA Go Ahead; Peak PlasmaBlade Wants to Be The New Bovie
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Tuesday, October 28, 2008
OsDx Stratifies Old Hips Before They Break
Imaging Therapeutics (ImaTx), Inc. from Foster City in Silicon Valley has received FDA marketing clearance for its OsDx™ Hip Bone Mineral Density (BMD) software system. Company's image-processing software can provide an estimate of BMD from a conventional x-ray of the proximal femur in pelvic radiographs, which will make osteoporosis screening and fracture prediction much more readily available than the current DXA (dual energy x-ray absorptiometry) approach.
From The ImaTx Website:
Only 5 percent of falls result in fractures suggesting that there are other non-fall variables that are likely co-determinants of hip fracture such as impact location, bone density and architecture, and proximal femoral geometry that influence the structural capacity of the femur.Bone mineral density measurements (BMD) successfully identify subjects at risk for fracture and can help physicians select those individuals who will derive greatest benefit from therapy. However, overlap exists in the distribution of BMD of patients with and without osteoporotic fracture, and BMD does not accurately predict the presence of fractures. Thus, factors other than BMD contribute to fracture risk. Key among those factors is alterations and disruptions of trabecular structure.
Substantial overlap exists in the distribution of BMD of patients with and without osteoporotic fracture and that BMD does not accurately predict the presence of osteoporotic fractures and cannot accurately assess absolute fracture risk in an individual patient.
Our preliminary data suggest that measurement of individual fracture risk is feasible using a combination of bone structural, morphometric and biomechanical measurements.
Several methods have been described to examine trabecular structure using conventional projectional radiography. The earliest analysis techniques used microdensitometer-analog computer methods and Fourier transformation techniques. Simple texture analysis tools were then applied indicating that simple geometric patterns can be used to discriminate between the hips of normal controls and patients with osteoporotic fractures. Caligiuri et al. reported that fractal analysis of bone structure using standard 2D radiographs has a significantly greater area under the ROC curve than BMD measurements in differentiating normal patients and patients with osteoporotic compression fracture. Clearly, these preliminary studies provide a strong indication that measurements of bone structure in the hip represent a feasible approach for diagnosing osteoporosis and predicting fracture risk. Our technique for assessment of bone structure in the proximal femur using conventional radiographs is shown
BMD is correlated with in vitro fracture load and can estimate fracture risk in groups of subjects, but is incapable of providing individual fracture risk, specifically adjusted for local bone structure, morphometry, and biomechanical conditions in a given patient.
Combinations of risk factors account for only 20% to 40% of the variability in bone mass and have little value in estimating BMD.
HFPS automated hip radiographic imaging technology measures parameters similar to those used in bone histomorphometry. In general, it involves x-ray digitization, identification of regions of interests, trabecular extraction, background subtraction to obtain an image of trabecular structures, and binarization of those structures.
Check out this white paper (.pdf) from Imaging Therapeutics about the company's technology for structural measurement of proximal femur in pelvic X-rays...
Press release: Imaging Therapeutics, Inc. Receives FDA Approval for Hip Bone Mineral Density
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Friday, October 17, 2008
Vertebral Crush Fractures...Balloons, Cement and More
Over a million new vertebral crush fractures (VCF) occur each year in the U.S, mostly as a result of osteoporosis, tumors, hemangiomas and trauma. Commonly treated with analgesia and calcitonin, other treatment options exist, such as bone cement fillers and balloon kyphoplasty. Kyphoplasty requires minimally invasive surgery to insert a balloon catheter in to the cancellous part of the collapsed vertebral body, inflating it to restore anatomical deformity, and then filling the defect with bone cement. It has been shown to significantly reduce pain and increase ambulation.
The latest press release by DFine Inc. details a novel technique for VCF treatment with company's proprietary polymethylmethacrylate (PMMA) formulated cement that responds to radiofrequency application to effect changes in the cement's viscosity. This allows for a one step, single injection site procedure that reduces physician exposure to radiation from fluoroscopy.
From the press release:
The physician can change the bone cement viscosity on demand, delivering an ultra-high viscosity, yet flowable, cement that forms an internal cast for stabilizing the fracture. The process can yield height elevation of the collapsed vertebrae while minimizing leakage of bone cement (extravasation)."The use of radiofrequency energy to give physicians the ability to control the viscosity of cement is novel and beneficial to both the physician and the patient," said Kieran J. Murphy, M.D., director of interventional neuroradiology at John Hopkins Hospital in Baltimore, Md. "The ability to minimize the leakage of bone cement is a large safety benefit I can present to my patients, providing them peace of mind in combination with much needed pain relief and improved quality of life."
The StabiliT Vertebral Augmentation System enables simultaneous cavity creation and filling. At the same time, the high viscosity of the cement may address the patient's fracture(s) with greater specificity through localized delivery of cement to compromised structures, providing a level of physician control of the cement that leads to optimized results for the patient.
Check out this DFINE technology video presentation...
Press release: DFine Launches StabiliT™ Vertebral Augmentation System and StabiliT™ ER Bone Cement at NASS...
Kyphon Inflatable Bone Tamps...
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Friday, October 10, 2008
Wellex Interspinous Process Medical Device Wins CE Mark
The EU has given green light to Eden Spine, out of Lake Mary, Florida, to market the company's Wellex device, described by its inventor, Dr. Jean-Marc Fuentes, as a "compressible dynamic extension controller that not only relieves pain but also positively affects the long-term health of the segment through its ability to dynamically control extension while protecting and maintaining the neutral zone."
Biomechanically, the Wellex maintains flexion, axial rotation and lateral bending but, more importantly, is not an extension blocker. Rather, it controls extension dynamically, thereby positively affecting the neutral zone and reducing disc and facet loading. Multi-level implantations are possible."The Wellex Interspinous Process Technology aims at perfecting the balance between motion and stability by restoring the posterior tension band, the facet congruence and the foraminal height," explained Mourad Ben Mokhtar, head of Eden Spine's research and developments efforts. "Its unique characteristics establish it as the latest generation of extension controllers, positioning it to be the gold standard for spinal patients who do not respond positively to conservative treatment, who are not willing to suffer the consequences of a fusion, and who are in need of pain relief from spinal stenosis."
Press release: Eden Spine Receives CE Mark for its Nonfusion Wellex(TM) Interspinous Process Medical Device
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Monday, October 6, 2008
ChonDux Aids in Operative Cartilage Repair
MIT Technology Review recently profiled a special material designed by Cartilix out of of Foster City, CA, that helps with bone marrow clotting during knee-cartilage repair surgery.
During microfracture, a surgeon uses a special awl to drill a series of tiny holes into the bone underneath the area of missing cartilage. Bone marrow containing stem cells seeps into the damaged area and forms a clot. The clot releases stem cells, which differentiate into cartilage cells and gradually form new tissue. However, because the new tissue is scar cartilage, not true cartilage, it may not have the same durability and strength as the original tissue--a likely contributor to the high failure rate of microfracture.ChonDux consists of a hydrogel made of polyethylene glycol--a polymer commonly used in a variety of medical products--and a bioadhesive to keep the hydrogel in place after injection. First, the surgeon coats the inside of the cavity where the cartilage is missing with the bioadhesive and then, as in microfracture, drills tiny holes into the bone next to the cavity. Then the surgeon fills the empty space with the hydrogel and shines UVA light on the material, which causes the polymer to harden from a viscous liquid into a gel.The blood clot that forms from the microfracture then gets trapped in the hydrogel.
More from MIT Tech Review..
Cartilix...
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Tuesday, September 30, 2008
Stuck in a Cast? MyoSpare Wants to Exercise Your Unused Muscles
Anyone who's ever wore a cast after breaking an arm or leg knows that muscles not used for a month or so become rather pathetic looking, and lack much of their original strength. An Israeli company called StimuHeal Inc. is working on embedding electrical stimulators inside casts to exercise the immobile muscles.
From Israel21C:
Now available in Europe and Israel, MyoSpare takes advantage of the downtime period when the adult or senior body is inactive and healing from an injury.Using existing equipment on the market, StimuHeal identified the technical and clinical limitations of activating the muscles underneath casts using Neuromuscular Electrical Stimulation (NMES), a well-recognized tool in the American healthcare system.
If electrodes were to be inserted under the cast, the company recognized, prolonged sweating would be a problem. They also had to develop the perfect stimulation regime so the lactic acid and CO2 wouldn't build up in the muscles, causing pain and discomfort. StimuHeal solved this by developing a microprocessor that calculates a cycle for the muscles to rest.
Not only will the MyoSpare device cut down on physiotherapy costs, it will radically help people return to their former selves after a serious debilitating injury. Other devices exist on the market to aid in muscle stimulation, but the MyoSpare is the only one developed for use under a cast when the body is healing, the company says.
To stay competitive, StimuHeal hopes to be able to sell MyoSpare in the United States for about $300, once it gets the FDA seal of approval. This should happen sometime in the next year.
More from Israel21C...
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Wednesday, September 17, 2008
Eon Mini, World's Smallest Spinal Cord Stimulator, Makes Clinical Debut
ANS / St. Jude Medical's Eon Mini implantable neurostimulator, a device we covered back in April when it was approved by the European and American regulators, has been implanted into the first patient. The recipient is Adam Hammond, a former member of the U.S. Army's "Golden Knights" Parachute Team, who was skydiving while on leave in 2006 when his parachute did not deploy correctly. The Eon Mini implantation was performed at the Center for Pain Relief in Charleston, W.Va.
To check out the features of the device, either head to our previous post, or to the product page at EonMini.com. Below is a rundown of the NeuroDynamix™ microchip technology that powers the device:
Thanks to breakthrough NeuroDynamix™ technology, ... enhanced Eon IPG is bringing unprecedented speed, power, and efficiency to you and your SCS patients. Utilizing a proprietary new microchip and enhanced software, NeuroDynamix technology delivers best-in-class power output. Seamless coverage with multiple independent arrays. Unmatched time between recharges. And much more. Which gives your SCS patients pain coverage, control, and sustainability like never before. And takes their relief to entirely new places.Power to Deliver and Sustain Successful Therapy
Eon IPG has the highest power output on the market—giving you extra capabilities for even the most challenging cases
Addresses high impedance levels and the need for increasing power requirements over time
Allows complex multi-site treatment while maintaining power at broad parameter range Speed and Frequency for Seamless Coverage
Proprietary Intelligent Discharge Technology™ enables high-frequency programming even when using multiple independent arrays
Microchip processing speed enables Dynamic MultiStim to seamlessly create broad, multifocal areas of stimulation
Provides patients with a perception of smooth, continuous coverage Efficiency to go the Distance
Intelligent NeuroDynamix microchip monitors power output and continuously switches modes to deliver the desired stimulation in the most power-efficient manner possible, extending battery life and maximizing time between recharges
Constant current circuitry automatically adjusts power output over time to maintain the prescribed current needed for pain relief
High-efficiency power management and the largest available battery capacity give patients the flexibility to recharge on a schedule that best fits their lifestyle, now and in the future
Press release: Former U.S. Army Parachutist Becomes First Person Implanted with the World's Smallest Neurostimulator to Treat Chronic Pain...
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Tuesday, August 19, 2008
Digital Lightbox Brings Minority Report to The OR (No Precognition Capabilities)
BrainLAB AG, out of Feldkirchen, Germany has recently installed its first Digital Lightbox radiology system in a Munich hospital. Designed to be installed in radiology departments, clinical floors, and operating rooms, the system behaves like a giant iPhone, simultaneously displaying volumetric images from various imaging modalities along with patient information.
Digital Lightbox replaces the conventional light box used to observe analog x-ray images. Connected to the hospital PACS, the new digital platform can be installed both in meeting rooms and in operating rooms, where clinicians can then access, manipulate, and utilize data for surgery planning. By displaying the human body in 3D, Digital Lightbox helps clinicians to more clearly demonstrate to patients what effects a disease can have and which procedures may be necessary.Digital Lightbox enables clinicians to select the most valuable images from large amounts of existing medical data. Ergonomic touchscreen technology with zoom functionality makes working with data easy and effective.
Clinicians can intuitively navigate within pictures and between settings. Image scrolling can be performed with one finger; zooming in and out of images with two. Images from different sources can also be fused easily. A measure functionality enables clinicians to set size and other dimensions.
By integrating the communication platform iPlan® Net from BrainLAB, clinicians can perform treatment planning with Digital Lightbox or any PC connected to the hospital network. This eliminates bottlenecks, as busy planning stations are rendered obsolete. iPlan Net helps to simplify the clinical workflow and save costs, as well as strengthen and simplify interdisciplinary collaboration between neurosurgery, nuclear medicine and radiology departments.
Digital Lightbox can be installed in any hospital environment and is compatible with all established image formats, such as DICOM, jpg, bmp, tif, png, avi, wmv. Planning data can be transferred directly from Digital Lightbox to surgical navigation systems designed for precise and minimally invasive procedures.
Video demonstrating the Digital Lightbox:
Press release: World Premiere at University Hospital in Munich: Digital Lightbox...
Product page: Digital Lightbox
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Wednesday, August 13, 2008
Long Lasting Spinal Cord Neurostimulator from St. Jude Gains Approvals
St. Jude Medical's ANS Division has received FDA and EU approvals for the EonC™, the longest lasting non-rechargeable neurostimulator of its kind.
The following product features are listed in St. Jude's press release:
The EonC neurostimulator provides a convenient option for chronic pain patients who prefer or require the simplicity of a non-rechargeable medical device. Featuring the greatest battery capacity of any primary cell neurostimulator, the EonC may maximize the time between device replacement procedures...Proprietary technology (called NeuroDynamix(TM)) which helps deliver stimulation with greater efficiency Advanced programming capability which allows patients to adjust therapy strength in up to eight pain areas simultaneously and independently Constant current circuitry which automatically adjusts power output to deliver consistent therapy over time High power and high pulse frequencies which enable clinicians to adjust the therapy to accommodate individual patient needs EonC is the only 16-contact, constant current, non-rechargeable system for SCS therapy
Product page: Primary Cell IPG Systems
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Thursday, August 7, 2008
Physio-L Lumbar Artificial Elastomeric Disc Gets EU OK
Nexgen Spine Inc., a New Jersey firm, has received EU approval to market its Physio-L® Lumbar Artificial Disc, a device based around polymeric elastomers. The material, according to the company, provides both strength and elasticity to better mimic natural disc performance.
From the product page:
The Physio-L™ Artificial Lumbar Disc is a weight bearing artificial intervertebral lumbar disc implant indicated for use between L3 and S1 in skeletally mature patients with degenerative disc disease (DDD). The device closely matches the physiologic properties of the intact human intervertebral disc and is comprised of a superior and inferior titanium endplate and a central elastomeric core.Single durometer poly-carbonate polyurethane core material selected for its static mechanical properties and biodurability
Elastomeric Core Geometry
1) Core deseign allows for physiologically unconstrained center of rotation and enhanced fatigue resistance.
2) Designed to restore normal range of motion n flexion/extension, lateral bending and torison.Dome Design
1) Titanium porous coated endplate dome for ingrowth.
2) 3mm high dome shape optimized to fit anatomic shape of the endplates.
3) Central keel to assist in achieving initial implant stability.
Press release: Nexgen Spine Receives CE Mark Approval for the Physio-L(R) Artificial Disc
Product page: Physio-L Artificial Lumbar Disc
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Tuesday, August 5, 2008
Personalized Bicompartmental Knee Implants from ConforMIS Go On Sale
ConforMIS, a Burlington, MA maker of orthopedic implants, has announced yesterday the availability of the firm's new personalized bicompartmental knee implants. The iDuo™ Bicompartmental Knee Resurfacing System is shaped to the individual recipient from his or her CT scans, the big idea being to reduce the size of the implant and therefore preserve more of the natural bone.
The iDuo is a bicompartmental resurfacing implant designed for patients whose arthritic damage is limited to either the medial or lateral compartment of the knee, in addition to the patellofemoral compartment. Approximately 30% to 50% of patients who receive a total knee replacement today exhibit symptoms of osteoarthritis in just one or two of the three compartments of the knee.The iDuo resurfaces only the affected areas, preserving far more bone on both the femur and tibia than traditional knee replacement surgery. The iDuo also preserves both the anterior and posterior cruciate ligaments, helping to maintain natural knee kinematics. The extent of tissue preservation with the iDuo helps patients retain their future surgical options.
Each iDuo is designed from an individual patient’s CT scan using the company’s proprietary iFit™ technology and made specifically for that patient. Because it is patient-specific, the iDuo allows for individualized fit, including full coverage of the tibial cortical rim, and a simplified surgical technique.
The iDuo comes packaged together with patient-specific instrumentation called iJigs™, which are designed from the same scans as the implant, including data on the patient’s biomechanical axis. The iJig cutting and placement guides eliminate manual sizing during surgery and provide tactile guidance to precisely place the instruments, simplifying the surgical technique. One tray of disposable iJigs replace multiple trays of traditional instrumentation that would typically have cost a hospital several hundred dollars per surgery in instrument handling, storage, sterilization and lost operating room time.
Press release: ConforMIS, Inc. Launches First Patient-Specific, Bicompartmental Knee Resurfacing System on the Market
Product page: iDuo™ Bicompartmental Knee Resurfacing Device...
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Monday, August 4, 2008
Hydrogel as a Repair Device for Torn Cartilages
Researchers at the University of Bradford's School of Engineering and the university's spinoff called AGT Sciences have been working on a new hydrogel with potential applications in orthopedics, wound care, and other clinical disciplines in which connective tissue matters.
Here's what AGT says about its product, promoted as "cartilage repair gel":
Our hydrogel is made up almost entirely of water, yet can thicken to produce a substance 100-1000 times stronger than any other gel of its kind.This is because it is composed of two very long elastic-like molecules that form strong covalent bonds with each other to form a 3D network, like a cage, that holds the water. By adjusting the number of bonds, the physico-chemical properties of the gel can be manipulated to make it thick, thin or sticky. The gel also has the capability to hold molecules of other substances, whether water soluble or water insoluble (e.g. oil).
Much of the company’s development has been undertaken using polyvinyl alcohol (PVOH) as the co-polymer. Our innovation, derived from research undertaken by our scientists at the University of Bradford, is a unique cross-linker, "PD2000", that is capable of bonding with a range of copolymers to form materials with a unique combination of useful properties.
A summary of the features of this technology includes:
Physical and Chemical Properties Able to form a wide range of hydrogels with different physico-chemical properties
Able to vary the physical form ranging from liquid to a solid
Solid can be formed with very high water content (90%+)
Cross-linking reaction can complete unaffected by the presence of other substances
Very high mechanical strength maintained even with high (90%+) water content
Can be extruded into films
Temperature and radiation resistant
Cross-linking reaction is reversible when desired Release and Absorption Properties
Can be used for sustained release of incorporated substances by virtue of zero order kinetics
Can be used to generate microemulsions – with the added capability of being able to ‘burst’ and release
Hygrostatic – maintains level of hydration Toxicity and Cell Biology
Non-toxic and meets current safety regulations
Intrinsically bacterostatic
Can be used as a medium for tissue growth
Product page: AGT Sciences hydrogel...
University of Bradford press release: Cartilage repair gel will improve quality of life...
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Wednesday, July 30, 2008
TriboFit Hip System Features Microelastohydrodynamic Lubrication (no more, no less!)
Over at Israel21c we found an interesting article about a company called Active Implants Corp. (AIC) that tries to commercialize a new, potentially revolutionary, 
hip replacement device called TriboFit® Hip System. The system is different from all the other ones because, in addition to standard acetabular cup and femoral head, the device features a proprietary TriboFit® Acetabular Buffer™, made of a gelatinous-like hydrophilic substance that is supposed to imitate the fluid film layer naturally present in joints. Some clinicians who already used the device reported that potential advantages of the system include "minimal reaming and a press-fit surgical technique. Furthermore, by ensuring that microelastohydrodynamic lubrication is maintained, friction can be nearly eliminated, thus decreasing the potential for wear."
According to Israel 21c, the device received the European CE Mark in September 2006. The company hopes to gain FDA clearance in the US soon.
To learn more: Active Implants...
Abstract at European Federation of National Associations of Orthopaedics and Traumatology: TriboFit Total Hip System for the Treatment of Femoral Neck Fractures in the Elderly: Preliminary results (.pdf)
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Monday, July 28, 2008
Force-feedback Offerings from Haption
Via a press release from Virtalis Ltd , a consultancy out of Manchester, UK, we learn about a French company Haption S.A. that is trying to expand the use of its haptic technologies in the medical market, such as for surgical training, rehab, etc.
According to Virtalis,
The Haption range encompasses a small, desktop device with a translational workspace within a sphere of diameter of 120 mm and rotational workspace of 35O in three directions. Top of the range is the Virtuose 6D35-45, which was designed for the 1:1 scale manipulation of virtual objects and has a massive transational workspace up to a sphere of diameter of 450 mm and can exert forces up to 35 N. All Haption products can be easily integrated into Virtalis StereoWorks installations, so that the Haption device is linked to 3D stereo projection in a fully tracked virtual environment.Aside from engineering applications, Haption is finding new customers in the kinehaptic field where patients overcome their injuries by practicing their fine motor skills. Surgeons who need to stay within a tightly controlled operating envelope represent another important market for haptics. So do nuclear engineers, whose complex operations when dealing with several robots carrying out specialized dismantling and decommissioning work, have found themselves benefiting greatly from virtual force feedback. In hazardous environments, being able to create the physics of an object, practice manipulating it, optimize the movement path and then record that path, has proved to be invaluable.
If you want to check out the brochure for the Virtuose 6D35-45 device, here it is (.pdf)...
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Thursday, July 24, 2008
PlasmaBlade System Gets FDA Go Ahead
Peak Surgical is happy to announce that the FDA has 510(k) OK'ed to market the company's plasma scalpel system for use in general surgery, a device we reviewed back in May. The system touts the precision of a standard scalpel and the cauterization abilities of the bovie, but without the accompanying burning of peripheral flesh and all the smoke.
The video below shows off the technology and demonstrates various cuts using the PlasmaBlade compared to scalpels and bovies.
Press release: PEAK Surgical Receives 510(k) Clearance to Market PEAK® Surgery System for Use in General Surgery...
Flashback: Peak PlasmaBlade Wants to Be The New Bovie