Wednesday, May 7, 2008
Peak PlasmaBlade Wants to Be The New Bovie
PEAK Surgical, Inc. from Palo Alto, CA hates the bovie cutter/coagulator. The company cannot stand the 1920's technology behind the bovie, and how its thermal function destroys healthy patient tissue around the cut. What do we hate about the bovie? Well, you know: all those bovie induced burns and destroyed gloves that surgeons are regularly subjected to.
Long story short, PEAK Surgical wants its Peak PlasmaBlade, a cold cutter and coagulator, to be the bovie of the 21st century. The company is quite hopeful: a new study presented in a poster session at the ongoing American College of Obstetricians and Gynecologists' (ACOG) 56th Annual Clinical Meeting in New Orleans showed that PEAK PlasmaBlade™ "cut freshly excised human abdominal tissue with little thermal tissue injury compared with traditional electrosurgery."
More about the technology:
Electrosurgery was invented in the beginning of the 20th century and became one of the most-often used surgical tools after William Bovie introduced his electrosurgery (radiofrequency) generator in 1926. Since then, electrosurgical cutting has been performed using continuous radiofrequency waveforms, which thermally vaporizes soft tissue via an electrical arc through air and Joule heating. This results in a cutting and coagulation action that leaves a wide zone of collateral thermal damage.By contrast, PEAK Surgical’s PULSAR Generator supplies pulsed waveforms that produce short plasma-mediated, highly controlled electrical discharges through extensively insulated electrodes on a handheld device -- the PEAK PlasmaBlade. Because the radiofrequency is provided in short pulses with low duty cycle (fraction of time the voltage is ON), and the PEAK PlasmaBlade is so highly insulated, heat diffusion and associated thermal damage to surrounding tissues is limited, resulting in greatly reduced collateral damage and extreme cutting precision.
PEAK Surgical’s technology including the pulsed plasma-mediated discharges and electrode insulation techniques were originally developed by Professor Daniel Palanker’s group at the Hansen Experimental Physics Laboratory and Department of Ophthalmology at Stanford University. They have been evaluated in ophthalmic applications, including human studies in retinal and cataract surgery – one of the most delicate, precise and difficult types of surgery, and in preclinical studies.
Check out the following product brochure distributed by PEAK Surgical:
Product page: Peak PlasmaBlade...
Press release: PEAK Surgical Announces Positive Results from Preclinical Study of PEAK PlasmaBlade™ for Obstetric and Gynecologic Surgery
Video demonstrating the device...
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Wednesday, May 7, 2008
Gore Receives EU's CE Mark for PRECLUDE Vessel Guard
Gore & Associates has received EU's approval to market its PRECLUDE vessel guard, developed to provide protection for vasculature following anterior spinal surgery for degenerative disc disease, just in case if these surgical patients have to return for a revision procedure. Anterior vertebral re-explorations have inherently increased risks of damage to major abdominal vessels, such as the aorta, the vena cava, and the iliacs.
GORE PRECLUDE Vessel Guard enables vasculature management in patients having undergone anterior spinal surgery for degenerative disc disease, including artificial disc replacement (ADR), where scarring around the aorta, vena cava, and iliac vessels can complicate revising, repositioning, or removing a disc prosthesis. An ideal biomaterial for intimate vessel contact and protection, GORE PRECLUDE Vessel Guard is soft and conformable with excellent handling characteristics. The tight microstructured membrane is inserted between the prosthesis and the vessels during the primary surgery. In a revision surgery, the vessels can be identified, dissected from the device and mobilized. GORE PRECLUDE Vessel Guard has a three-layer construction with two outer layers consisting of a tight expanded polytetrafluoroethylene (ePTFE) microstructure preventing penetration by fibroblasts, thus minimizing vascular tissue attachment to the device, allowing safer anterior revision. GORE PRECLUDE Vessel Guard is also easy to use--an elastomeric inner layer minimizes impingement and provides the stiffness needed for accurate placement. The material may be trimmed and tailored without fraying.The U.S. Food & Drug Administration (FDA) cleared GORE PRECLUDE Vessel Guard indicated for vessel protection in August 2006.
Press release: Gore Receives CE Mark for GORE PRECLUDE® Vessel Guard
Video (Windows Media): 14-Month Revision Surgery with a GORE ePTFE Membrane
Product page...
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Tuesday, May 6, 2008
VascuSeal Goes on Sale in Europe
Covidien, a US company with executive headquarters in Bermuda, is introducing its CE Mark approved vascular sealant system to the European market.
Unlike a hemostatic agent, a vascular sealant can seal blood leaks and does not depend on either the time for the blood to clot or the strength of the blood clot to perform successfully. The VascuSeal(TM) Sealant System offers surgeons a valuable tool to reduce bleeding from the suture line in vascular bypass procedures, and reduces post-operative complications associated with suture line bleeding.The VascuSeal(TM) sealant technology is a patented synthetic, absorbable hydrogel delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. VascuSeal(TM) sealant polymerizes within seconds when sprayed on the suture line and is blue in color which provides the vascular surgeon visualization of coverage and thickness of the material upon application. Postoperatively, VascuSeal(TM) sealant continues to seal the suture line as healing progresses under the gel. After several days, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.
Press release: Covidien Introduces the VascuSeal(TM) Vascular Sealant System to the European Marketplace
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Friday, April 25, 2008
Vasovist, a Vascular MRI Contrast Agent, Meets FDA Requirements
Epix Pharmaceuticals Inc., an Israeli firm that has developed Vasovist (gadofosveset trisodium), a novel MRI contrast agent, has announced that its product "has achieved positive results from the blinded, independent re-read of images of its novel blood pool magnetic resonance angiographic (MRA) agent, Vasovist. In the re-read of images obtained from previous phase 3 studies, EPIX met all pre-specified endpoints prospectively agreed to with the U.S. Food and Drug Administration (FDA). EPIX plans to resubmit a New Drug Application (NDA) to the FDA for Vasovist in mid-2008. Vasovist is currently approved for marketing in 33 countries." And that includes the European Union, where the device (as it is classified) has been marketed (in collaboration with Schering AG) since 2005.
Here's how the agent is described:
Vasovist® is an injectable intravascular contrast agent discovered internally at EPIX and is designed to provide improved imaging of the vascular system using magnetic resonance angiography (MRA). EPIX's initial target indication for Vasovist is for use in MRA imaging of peripheral vascular disease, providing a breakthrough in the physician's ability to visualize the human vascular system and improve disease diagnosis and treatment.Vasovist reversibly binds to the human blood protein albumin, allowing imaging of the blood vessels for approximately an hour after administration. With a single injection, Vasovist enables clear three-dimensional images of arteries and veins throughout the body. Vasovist may make it possible for physicians to detect vascular disease earlier and less invasively than with X-ray angiography, and provide an improved evaluation of potential therapeutic options including percutaneous intervention and vascular surgery.
Press release: EPIX Pharmaceuticals Announces Positive Results From Re-Read of Vasovist(R) Phase 3 Images...
Product page: Vasovist...
More from Globes: Epix imaging device meets FDA requirements...
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Wednesday, April 23, 2008
Angiotech Suspends Vascular Wrap Trial Enrollment
Angiotech Pharmaceuticals, a Vancouver, BC company, has announced suspension of enrollment in its U.S. and EU human clinical trials for the company's Vascular Wrap product candidate "in patients undergoing surgery for hemodialysis access, pending a safety review to evaluate an imbalance of infections that have been observed between the two study groups." Vascular Wrap is a paclitaxel-eluting surgical mesh that was designed to inhibit the growth of scar tissue (neointimal hyperplasia) inside a synthetic vascular graft, thought to decrease failure rates of dialysis access catheters. The product, that has shown promise in an animal model, has now hit a snag.
The company explains:
The U.S. and EU trials each consist of two study groups; (1) patients who received the graft / Vascular Wrap ombination; and, (2) patients who received the graft alone.At the onset of this study Angiotech established an independent Data Safety Monitoring Board (DSMB) in the U.S. to monitor any unexpected risks or safety issues. Angiotech recently submitted a safety summary of adverse events from the U.S. clinical trial to the DSMB, based upon having reached the 25% enrolment threshold in the U.S. clinical trial. Subsequent to that submission, Angiotech received a communication from the DSMB that one of the study groups had a greater incidence of implant site infection in comparison with the other study group.
Angiotech is blinded to the groups and not currently aware of whether the increased rate of infection is in the patient group that received the graft / Vascular Wrap combination or in the patient group that received the graft alone. As a result of these observations, Angiotech has elected to notify physicians to suspend further enrolment in the trials, pending a full review of the potential cause of the implant site infections.
“We regard patient safety as the paramount obligation of any company in our industry, and upon further adjudication of the clinical data, we hope to identify the underlying cause of these observed events, and to make a prudent and sensible decision regarding the future of this clinical development program,” said Dr. Jeff Walker, Chief Scientific Officer of Angiotech.
Product page: Vascular Wrap...
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Friday, April 18, 2008
Medtronic Defender Embolic Protection Filter Approved in EU
This device, newly approved for the European market, is designed to get rid of nasty emboli that can occur during a variety of stenting procedures:
Made of braided nitinol (a “memory metal” that resumes its original shape upon deployment), the Defender embolic protection filter has a low profile and a peel-away delivery sheath that enables physicians to maneuver the device easily across lesions to the desired location. When opened, the filter acts as a basket, allowing sufficient blood flow while simultaneously trapping dangerous embolic debris that may become dislodged during the stenting procedure. Without this protection, embolic debris can flow into other portions of blood vessels – and, in the case of patients with carotid artery disease, this can lead to a stroke, one of the world’s leading causes of death and long-term disability...The Defender filter has a 2.2 French (0.029 inch) crossing profile and an extendable 0.014 inch stainless steel core wire that is designed for both flexibility and support. Also, the device’s mesh filter basket design allows the filter to fit snugly against vessel walls, even in eccentrically shaped vessels. This reduces the risk of embolization by preventing particles from migrating through gaps and into the blood stream. Another key feature of the device is its steerability and guidewire-like torque response, which measures the number of revolutions needed to turn the tip 180 degrees within the sheath. Bench testing shows the Defender filter to have improved torque response.
“Torque response is a key attribute for a filter, and Defender performed very well, with a 1-to-1 torque response between the proximal and distal tip of the wire,” said Dr. Dierk Scheinert, director of the Park-Hospital Leipzig and head of the Department of Angiology at the University of Leipzig Heart Center. “We were impressed with the trackability of the system. One of the cases had a long lesion (2 cm) to cross, and the filter went through without any issue.”
Press release: Medtronic Announces CE Mark and European Launch of New 'Defender' Embolic Protection Filter ...
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Thursday, April 17, 2008
FDA OK's Endovascular Talent Stent for AAAs
Medtronic's minimally-invasive Endovascular Talent™ for AAAs, first mentioned in Medgadget back in December 2007, has now been approved for marketing in the United States.
The Talent Abdominal Stent Graft System makes endovascular repair (EVAR) accessible to an additional 20 percent of AAA patients, because of its unique proximal aortic neck length requirement of only 10 mm. Consisting of a woven polyester membrane supported by a tubular metal lattice, the device is specifically indicated for endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. The stent graft is available in diameters of up to 36 mm, as well as flared and tapered iliac limbs of 8 mm to 24 mm.With a 12-year history of strong clinical performance including more than 45,000 implants worldwide, the Talent Abdominal Stent Graft is designed to offer broad patient applicability, suprarenal fixation and positioning accuracy. The stent graft features radiopaque markers for visual guidance during deployment and follow up, and the delivery system uses a single-step release mechanism for smooth deployment and a coiled rod for enhanced trackability and flexibility...
The Medtronic-sponsored clinical study of the Talent Abdominal Stent Graft System enrolled 166 patients at 13 medical centers between February 2002 and April 2003. All 166 patients received a Talent Abdominal Stent Graft; their outcomes were compared to those of 243 patients from the Society of Vascular Surgery (SVS) Surgical Control Group at 30 days and one year post-implant. Dr. Frank Criado, director of Union Memorial Hospital’s Endovascular Program in Baltimore, was the principal investigator for the study.
The study demonstrated that the Talent Abdominal Stent Graft well exceeded the SVS Control in freedom from major adverse events at 30 days, with a statistically significant difference between the two groups: Talent, 89.2%; SVS Control, 44.0%. Although patients receiving the Talent Abdominal Stent Graft were older and had a higher baseline rate of co-morbidities, at 30 days post-implant they experienced lower rates of major adverse events compared with subjects treated with open surgery. Importantly, there were no aneurysm ruptures and no conversions to open surgery in the Talent group up to 12 months after device implantation...
In previous studies, EVAR has been shown to be an effective therapy for AAA, with fewer postoperative complications and shorter recovery times than open surgical repair. Results from a U.S. study published recently in The New England Journal of Medicine (Jan. 31, 2008), for example, indicate that perioperative mortality was significantly lower after EVAR than after open repair: 1.2 percent vs. 4.8 percent – a fourfold difference. Similarly, in a landmark study conducted in the United Kingdom and published in The Lancet (Sept. 4, 2004), the 30-day mortality rate for EVAR patients was 1.7 percent compared to 4.7 percent for patients who underwent open repair – a nearly threefold difference.
Press release: FDA Approves Medtronic's Talent™ Abdominal Stent Graft for Repairing Aortic Aneurysms...
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Tuesday, April 15, 2008
Open Aortic Stapler Approved in EU
Just over two weeks ago we covered the Open Aortic Stapler from Israeli ES Vascular, Ltd, a device designed to allow for "one shot stapling of synthetic grafts to aorta in open repair of abdominal and thoracic aneurysmal and occlusive disease, replacing lengthy and cumbersome manual suturing in these major procedures". The company just announced that the EU has awarded the device with a CE Mark of approval for marketing in Europe.
Product page with video demonstrating the device: Staplers for Open Aortic Surgery
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Monday, April 7, 2008
NeuroFlow Cath Promises to Save Ischemic Brains
CoAxia, Inc. of Maple Grove, MN, is a firm developing an aortic device designed to restrict blood flow in the descending aorta, in the hope of diverting blood flow from the lower extremities to the brain via the cerebral collaterals, in patients with acute ongoing stroke. 
According to the latest reports from the company, "CoAxia's ongoing SENTIS clinical trial has now passed 125 patients with participation from over 50 major stroke centers in North America and Europe. Analysis of interim safety data suggests that treatment with CoAxia's NeuroFlo(TM) catheter is well tolerated with a very low rate of the complications normally associated with stroke patients. In addition, the FDA has recently approved an expansion in the scope of the trial to now treat patients up to 14 hours after symptom onset."
Here's what we know about the company's NeuroFlo catheter:
The CoAxia technology is a potential alternative or complement to these clot-focused techniques. The brain has an extensive, interconnected collateral vascular network. Already somewhat active following an ischemic stroke, collateral pathways are capable of further increasing the delivery of oxygenated blood to the stroke’s ischemic penumbra. The ability to salvage that penumbra and minimize the eventual size of the infarct may lead to improved neurological recovery.CoAxia has developed the NeuroFlo™ catheter as a device for augmenting the blood flow to the brain, and in particular to increase blood flow in the collateral blood vessels to augment perfusion in the ischemic penumbra. NeuroFlo partially restricts blood flow in the descending aorta, diverting blood flow from the lower extremities to the cerebral collaterals. The NeuroFlo catheter itself is a unique, dual-balloon endovascular device. It is inserted through the femoral (leg) artery into the descending aorta and has independently inflatable balloons located immediately above and below the renal (kidney) arteries. The balloons are sequentially inflated to produce occlusions of approximately 70%. The balloons are left inflated for 45 minutes and are then removed and treatment is complete.
This concept was first tested through animal experimentation which demonstrated that partial aortic occlusion could be accomplished without significant side effects, cerebral perfusion could be rapidly and significantly increased, and the size of a resulting infarct could be reduced. In April 2002, the first clinical studies began in humans to demonstrate the safety of the procedure. The images shown on this page (click to enlarge) are taken with a variety of techniques from patients treated with the NeuroFlo catheter.
In 29 stroke patients treated during CoAxia’s feasibility studies 61% of patients improved by more than 3 NIHSS points during the NeuroFlo procedure and 62% had an improvement of 3 NIHSS points at 24 hours. The significance of this improvement is reinforced by the fact that the average time to treatment in these patients was 7.5 hours after the symptom onset - well beyond the 3 Hour treatment window of the FDA-approved intravenous tPA. These feasibility results provided the basis for CoAxia’s current SENTIS pivotal trial, and its recent SafeFlo24 feasibility study (see ongoing clinical trials).
NeuroFlo, as the first device designed to utilize the brain’s own collateral, blood vessels, has a number of potentially important benefits. First, it does not involve intracranial access, instead requiring only a simple aortic placement – a procedure performed at thousands of hospitals throughout the world. In addition, since the therapy does not attempt to remove or disturb the clot, it may be less likely to cause hemorrhage – a common complication of other acute stroke treatments. In fact, current treatments are generally not attempted beyond 3-6 hours post stroke for this reason. NeuroFlo has been evaluated up to 12 hours beyond onset and could become a viable treatment alternative for the hundreds of thousands of patients that are too late to treat with current options.
Product page: NeuroFlo™ catheter...
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Friday, March 28, 2008
Open Aortic Stapler from ES Vascular
Open Aortic Stapler (OAS), a product from Israel based ES Vascular Ltd., is designed to simplify the anastomosis of synthetic graft to the aorta during AAA repair. The company is reporting that its stapler is past the development stage, and is now awaiting CE Mark of approval from the European Union. The company is working on other products, such as Endovascular Stapler (EVAS) "designed to fixate stent-grafts in place potentially preventing migration and possibly endoleakage," and CLI Endostapler that "will facilitate a minimally invasive procedure that can replace an open femoral-popliteal bypass (FPB) operation."
More about the Open Aortic Stapler:
ES Vascular's single use Open Aortic Stapler (OAS) provides a one-shot, perfect anastomosis while connecting a synthetic graft to the aorta for AAA repair.The quick, uniform, one-shot sutureless anastomosis may eliminate up to 90% of suturing time and reduce clamping and operative times as well as re-clamping cycles and bleeding.
AAA procedures are mostly open, dangerous (ca. 5% mortality), lengthy (2-3hrs) and require quite a long in-hospital stay
Suturing the difficult graft-aorta anastomosis accounts for both long clamping times (up to 50% of operative time) and re-clamping cycles, a major risk for the patient
Technical obstacles (e.g. highly calcified aorta) hampered the development of stapling technology for vascular surgery to date
ES Vascular's Open Stapler creates a quick, uniform, one-shot sutureless anastomosis and may eliminate up to 90% of suturing time, reduce clamping and operative times as well as re-clamping cycles and bleeding
More from Globes...
To understand how the device works, check out this product page and watch the video...
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Tuesday, February 19, 2008
Metricath Gemini Double Balloon Catheter Showing Promise
Medical Ventures Inc., a Richmond, BC, Canada company, is releasing results from a clinical trial, titled GAAME (Gemini Angioplasty and Arterial Measurement Evaluation), that tested an innovative double balloon catheter. Gemini® catheter is designed to have a dual function, as it has the balloon that works as the measurement tool to evaluate arteries prior to dilation, as well as a angioplasty treatment balloon. Currently the device is promoted for use in peripheral arteries, but one doesn't have to be a cardiologist to realize that the company would really want to see its device in coronary arteries everywhere.
Some of the reported results from the firm's press release:
Metricath was used to measure reference vessels and to pre-dilate (open up) lesions prior to stent implantation in 62% of cases (90/145). Direct stenting (implantation of a stent without pre-dilating the vessel in advance) occurred in 38% of cases (55/145). In 43% of pre-dilation cases (39/90), Metricath measurements influenced the target diameter for the treatment area. In 49% of pre-dilation cases (44/90), Metricath measurements influenced the physicians' stent size selection. Metricath measurements influenced the decision to post-dilate stents in 45% of direct stenting cases (25/55) and in 21% of pre-dilation cases (19/90).
Medical Ventures submitted a pre-market approval application for the device in November 2007 with the FDA.
Press release: Medical Ventures GAAME clinical update (.pdf) ...
Product page: Metricath Gemini® balloon catheter ...
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Friday, January 25, 2008
z.one ultra System
KLAS, a technology consultancy, has released its 2007 Best in KLAS report that features a ranking of what they believe are the top 20 overall medical technology companies (plus a ranking within specific fields). ZONARE Medical Systems, Inc. (Mountain View, Calif.) is one of the companies chosen, as the top hand carried ultrasound (HCU) vendor for its z.one ultra System.
Zone Sonography technology has enabled ZONARE Medical Systems to bring its unique, patented Convertible Ultrasound platform to the industry providing premium image quality and performance together with greater portability at an attractive price to value ratio compared to conventional ultrasound systems. Clinicians are able to convert the z.one system, at the touch of a button, from a full-featured, cart-based system into a premium compact ultrasound system, optimizing its versatility in a variety of clinical settings, without sacrificing image quality or performance.Unlike most other HCU systems, the z.one system's Zone Sonography software-based architecture allows its performance to continue to improve as greater processing power becomes available. System upgrades can be downloaded via the internet, allowing for fast, convenient advances in clinical capabilities, enabling clinicians to cost-effectively maintain a state of the art premium ultrasound system.
Press release: ZONARE RANKED BEST IN KLAS AS HAND CARRIED ULTRASOUND VENDOR IN 2007 TOP 20: YEAR-END REPORT
Product page: z.one
Top 20: 2007 Best in KLAS report can be conveniently purchased for $2,500 from KLAS...
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Tuesday, January 15, 2008
ReeTrakt Surgical Retractor
Insightra Medical Inc. of Irvine, California has just been granted the European CE Mark to sell what the company calls a "new generation" of disposable soft-tissue surgical retractors.
ReeTrakt is the new generation of disposable soft-tissue surgical retractor systems providing complete retraction flexibility and optimal exposure of view in a variety of surgical procedures. It has been designed in conjunction with Nanyang Technological University (NTU) Singapore for surgeons to gently retract and secure the delicate soft tissue away from the operative site. Apart from being designed to make access to surgery easier and more efficient, ReeTrakt is also designed to minimize tissue trauma, optimize retraction force and lower the risk of infection. ReeTrakt allows the surgeon to perform the procedure with less assistance, in some cases facilitating procedures to even be performed single-handedly.
"ReeTrakt introduces a novel concept for use in pelvic organ prolapse (POP). The placement of four hooks (two superiorly and two inferiorly) could completely replace the need for a second assistant. It should allow a much better field of view and improved access," said Dr Mark Slack, Head of Department, Urogynecology and Pelvic Reconstructive Surgery, Addenbrooke's Hospital, Cambridge University Hospital NHS Foundation Trust, Cambridge, U.K.Because of the versatility of ReeTrakt's design, which can be customized and catered to a wide variety of surgical procedures, it is anticipated that ReeTrakt will eventually be used in dozens of types of surgical procedures on a global basis.
Now available in the US and Europe. Here are the features that the company is trying to emphasize:
Low profile
Follows the body contours
Optimizes the view of the wound
Highly stable platform
Simple device
Hands free usage
Single Patient Use
Product page: ReeTrakt...
Press release: Insightra® Medical Inc Receives CE Mark on Revolutionary New Surgical Retraction System
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Wednesday, December 5, 2007
Endovascular Talent™ for AAAs
Medtronic, Inc. has filed a Pre-Market Approval (PMA) application with the FDA for the company's new Talent™ Abdominal Stent Graft System. This endovascular device is similarly designed, and is in the same family, with previously reported Talent™ Thoracic Stent Graft System for descending thoracic aneurysms.
The Talent Abdominal Stent Graft is designed to offer broad patient applicability and ease of use, and a history of established clinical performance with more than 40,000 implants worldwide. The results of the clinical trial demonstrated that the study met its primary safety endpoint of superiority in freedom from major adverse events at 30 days, and the aneurysm-related mortality rate at 12 months was 1.8 percent. Although patients receiving the Talent Abdominal Stent Graft were older and had a higher baseline rate of co-morbidities, they experienced lower rates of death, myocardial infarction, respiratory failure, paraplegia, and blood loss compared with subjects treated with open surgery at 12 months. There were no aneurysm ruptures and no conversions to open surgery in the Talent Abdominal Stent Graft group up to 12 months after device implantation."As part of the FDA's modular review process, we have submitted the final module -- a comprehensive clinical data set for the Talent Abdominal Stent Graft PMA application," said Katie Szyman, vice president and general manager of the Endovascular Innovations business at Medtronic. "The Talent Abdominal System will expand treatment options for patients with abdominal aortic aneurysms and provide a strong complement to our market-leading AneuRx® AAAdvantage Stent Graft."
Press release: Medtronic Files PMA Application for FDA Approval of Talent Abdominal Stent Graft System ...
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Wednesday, November 28, 2007
Acuson P50 Portable Ultrasound System from Siemens
At the Medica conference in Düsseldorf, Siemens unveiled its Acuson P50 portable ultrasound laptop system. Based on the Apple MacBook, the laptop can be used for anything from echocardiography to browsing through YouTube.
The system provides superb image resolution in B mode and in color Doppler mode. It also includes an integrated stress echo function. It can run several cardiology application packages including syngo Velocity Vector Imaging (VVI) and syngo Arterial Health Package (AHP) which can used to determine a patient's vascular age. Together with syngo Auto Left Heart, these applications turn the P50 into an ideal solution which considerably simplifies and accelerates the workflow in echocardiography and vascular diagnosis.The Acuson P50 is a Microsoft Windows-based PC equipped with such additional functions as Microsoft Office Word, Microsoft Office PowerPoint and many other special image viewing programs. The system's flexible architecture provides for excellent ultrasound images and gives users a number of tools for image post-processing, for generating protocols or for accessing the Internet for additional research. During the examination, the physician is able to view other images, look at technical papers or clarify abnormalities before he making a diagnosis. This gives physicians more flexibility during the diagnostic process.
The Acuson P50 weighs slightly more than 5 kilograms and is easily transported in a laptop bag. When not connected to the Internet, it has up to two hours of battery life, making it fully equipped for emergency situations. The P50 is built off of an Apple MacBook laptop with 2 GB RAM, a 160 GB hard disk and a 2.0GHz Intel Dual-Core Pentium M processor.
(hat tip: The Raw Feed)
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Tuesday, November 27, 2007
AquilionONE CT from Toshiba Cleared by FDA
At the ongoing RSNA 2007 conference, Toshiba has unveiled its new dynamic volume CT system AquilionONE, a device that features, in addition to improved visualization and productivity, a 650 lb table capacity:
For the first time, physicians can see not only a three-dimensional depiction of an organ, but also the organ's dynamic blood flow and function. Unlike any other CT system, the AquilionONE can scan one organ - including heart, brain and others - in one rotation because it covers up to 16 cm of anatomy using 320 ultra high resolution 0.5mm detector elements. This reduces exam time, as well as radiation and contrast dose, and dramatically increases diagnostic confidence. With the AquilionONE, the organ or area is captured in a single rotation at one moment in time, eliminating the need to reconstruct slices from multiple points in time.
Press release: TOSHIBA'S AquilionONE RECEIVES FDA CLEARANCE ...
Product page...
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Monday, November 26, 2007
Artis zee from Siemens
At the ongoing RSNA 2007 conference, Siemens has introduces a new family for interventional fluoroscopy imaging, a group of devices featuring multi-axis capabilities based on robotic technology. The first device in this class is Artis zeego, a system currently awaiting 510(k) approval by the FDA.
From the product brochure:
Artis Artis zeego is a multi-axis, angiographic system for interventional procedures. It has more freedom of positioning to accommodate nearly all projections. Fluoroscopy can be performed easily on the patient from head to toe. With a flexible isocenter that enables the physician to adjust the exam table to the most comfortable working position, operation is easy and precise. The syngo DynaCT application has been expanded and can be used even more flexibly for 3D reconstruction, because a larger volume is covered, expanding the view of the patient's anatomy. Not only are individual parts of the body imaged, but the entire abdomen. Images are acquired in landscape or portrait mode. In addition, Artis zeego's flexible park positions make it ideal for hybrid rooms. The very first Artis zeego system in the world is located at the Institute for Clinical Radiology of the University of Munich.The Artis zee family portfolio also features dedicated C-arm systems for interventional cardiology and electrophysiology In this special field of intervention, excellent image quality is key. Imaging a moving structure such as the heart has always been a challenge. Now, with the Artis zee imaging system, outstanding image quality is provided from 2D fluoroscopy and 3D imaging and even a 4D image application where the time phases of the heartbeat are taken into account. In 2D fluoroscopy, features like advanced temporal filtration use an intelligent motion detection algorithm. This technology separates moving from non-moving structures in real time to improve the clarity of therapeutic instruments. Intelligent noise reduction enables high image quality during live fluoroscopy and acquisition by significantly reducing quantum noise without an increase in dose.
Stent meshes can be difficult to see, especially in obese patients or when steep angulations are used. But IC Stent* uses the balloon markers of the deployment balloon as reference points to shift and match images. Those images are then integrated to improve the signal-to-noise ratio to significantly enhance the visibility of stent meshes. For 3D applications, syngo IC3D helps to accurately measure lesions in the coronary arteries by using two projections. From these projections, a 3D model is generated so that a vessel can be rotated freely in space to precisely assess a lesion's diameter profile and the degree of stenosis. It also enables accurate measurement of lesion length to simplify appropriate stent selection.
The latest application, syngo DynaCT Cardiac, widens the 3D spectrum to 4D. By using rotational angiography and special reconstruction algorithms, syngo DynaCT Cardiac creates CT-like images of the beating heart right in the cath lab. During acquisition, it can use an ECG-triggered mode to collect image data to acquire only images from the same heart phase. With this feature it is now possible to reconstruct 4D images of the heart and its vessels in the cathlab.
And here's the full product brochure:
Press release: Siemens Introduces Its New Generation of Artis Interventional Imaging Systems...
Product page...
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New Surgical Instruments from KLS Martin Group
More news from German manufacturers, thanks to recent presentations at the medical devices and technologies conference Medica 2007 in Düsseldorf. According to German Healthcare Export Group, KLS Martin, a surgical device manufacturer, has just released a number of interesting innovative devices:
Another new instrument is the marSeal. It is a bipolar sealing system. The reusable sealing system with the new mar seal instrument secures permanent occlusion of veins, arteries and tissue bundles with subsequent dissection and no instrument exchange required! A great Advantage that carry weight is the cost reduction due to minimized use of disposables. Disposable blade guarantees optimal cutting results in any situation. Modular system with different shaft lengths can be used in laparoscopic and open surgery. Above that an easy cleaning is guaranteed because the instrument can be taken apart completely and is autoclavable at 134°C (273°F).
The newest bipolar sealing system marClamp® in combination with the current type SealSafe® offers the possibility of sealing veins, arteries and tissue bundles. A secure hemostasis can be achieved, comparable to classical hemostasis methods applying mechanical clamps and ligation techniques
The Advantages of the system are time saving, as well as an easy set-up and handling. There is no use of foreign material thus no foreign body reactions and better wound healing is guaranteed.
In oncosurgery the tumour cells are destroyed in the SealSafe® zone Furthermore ensure different clamp sizes a wide range of applications.
The Universal HF generator can be used for all surgical disciplines.
Also, according to the company's press release, they just introduced SoftScan plus R, the new highly sophisticated laser system for robotic microsurgery on the vocal cords.
Check out the following product brochures (all .pdf files) for the devices mentioned above:
marSeal for bipolar vessel sealing ...
SoftScan plus R in combination with micromanipulator "Micro Point"...
German Healthcare Export Group's press release...
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Friday, November 16, 2007
FusionOptic™ Technology from Leica
We've seen quite a few devices that are designed to improve all sorts of neurologic functions. However, we've never seen a medical gadget that is designed to utilize normal human neurology for improvement of its own function. And that is what FusionOptic™ Technology from Leica is supposedly doing: increasing the resolution of stereomicroscopes, models M205 C and M165 C, by delivering two different images to each eye.
From the press release about Leica M205 C, a model just introduced at the Medica 2007 in Düsseldorf (shown above; M165 C model is shown below).
The new Leica M205 C breaks through the previous optical resolution limits of stereomicroscopy by incorporating Leica's new FusionOptic™ technology (patent pending) which takes advantage of a neurological phenomenon. The left beam path produces great depth of field, while the right beam path provides a high-resolution image. The human brain then combines the best information from both channels to compose an image whose resolution and depth of field have never been achieved in any stereomicroscope before. The Leica M205 C is the world's first stereomicroscope with a fully apochromatically corrected 20.5:1 zoom. In the zoo