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SurgiVision has received FDA clearance for its ClearPoint system for MR guided neurological interventional procedures. It allows for precise targeting of lesions within the brain. The system consists of a disposable, MRI-compatible head-mounted adjustable trajectory frame; a multi-channel imaging head coil with integrated head fixation frame; a workstation and an MRI compatible computer and monitor with navigational software; and lastly, a complete MRI compatible surgical kit. The system can be used in existing MRI suites.

Demo video here…

Press release: DARA BioSciences Reports on SurgiVision Receiving FDA Clearance to Market Its ClearPoint System…

Product page: SurgiVision ClearPoint…

A Jersey cat, who had his back paws sliced off in an accident with a combine harvester, has received a pair of innovative prosthetic legs. Noel Fitzpatrick, a veterinary surgeon from Surrey, used a technique called intraosseous transcutaneous amputation prostheses (Itaps) to get the cat back on his feet. These prostheses grow through the skin in a way similar to the way deer antler bone does. This in contrast to the way most prosthetic limbs are attached by a “stump socket”, which often causes problems through rubbing and pressure sores. The new technology is currently being tested for application in humans. A documentary about the procedure called “The Bionic Vet” will be aired on BBC 1 this Wednesday.

BBC news story: A cat from Jersey has shot to fame as the ‘bionic cat’…

St. Jude Medical has received the European CE mark for yet another ablation catheter, its Therapy Cool Flex ablation catheter. It is the first ablation catheter with a fully-irrigated and flexible tip available for treating cardiac arrhythmias. It has a flexible coil spring-loaded and laser-cut tip with irrigation slits in a zig-zag pattern to accommodate cardiac anatomy and to ensure efficient cooling of the tip. Conformation with the endocardial contours ensures efficient energy delivery. The catheter is not yet available in the United States.

Press release: St. Jude Medical Announces European Approval of Industry’s First Flexible Tip Ablation Catheter

Kensey Nash has received FDA clearance for the firm’s Meso Biomatrix porcine-based mesothelium extracellular matrix. Developed for use during soft tissue repair to reinforce weak regions, the Meso Biomatrix is manufactured using Kensey Nash’s Optrix method of clearing porcine tissue of cells, viruses, and just about anything else that’s not the structural tissue matrix.

Kensey Nash Corporation’s Meso BioMatrix™ Surgical Patch is a resorbable porcine mesothelium-derived surgical mesh intended for reinforcement of soft tissues. The Meso BioMatrix Surgical Patch is a porcine-based mesothelium extracellular matrix designed to reinforce soft tissues where weakness exists in patients requiring soft tissue repair. Medeor™ Matrix, Kensey Nash’s previously cleared porcine dermis derived surgical mesh, and the Meso BioMatrix product are manufactured using Kensey Nash’s proprietary Optrix™ process, which gently disinfects tissues, inactivates viruses and removes cells while preserving extracellular matrix components and structure.

Meso BioMatrix Surgical Patch is a strong, flexible patch that can be sutured over a soft tissue repair site in order to reinforce the tissue during healing or to repair a damaged soft tissue. The patch will act as a temporary scaffold, preventing gaps from occurring between the juxtaposed tissues, and is eventually resorbed by the body and replaced by the patient’s own soft tissues.

Press release: KENSEY NASH Receives FDA 510(k) Clearance for ECM Product, Meso BioMatrix Surgical Mesh…

Out of San Diego, CA, Volcano Corporation has announces 510(k) clearance, CE Mark approval, and first clinical use for the PrimeWire PRESTIGE Pressure Guide Wire for use in patients who have both single-vessel and multi-vessel coronary artery disease. The next-generation guidewire provides functional measurements of blood pressure and flow parameters from inside the vessel to aid physicians in multi-vessel disease decision-making.

From the press release:

The PrimeWire PRESTIGE™ Pressure Guide Wire has a redesigned core intended to improve mechanical performance, such as torque transmission, vessel navigation, and support. A recent internal study confirmed that PRESTIGE™ substantially outperformed the previous generation PrimeWire® with respect to torque transmission. The redesigned tip also improves tactile feel and tip shape memory. PrimeWire PRESTIGE™ will launch simultaneously with the new upgraded v3.2 Software for the Volcano s5i, which provides an optimized FFR workflow for ease of use.

"The clinical data from the FAME study supporting the use of FFR to guide stent placement in multi-vessel disease patients is very strong, and has led to the upgrade of ACC/AHA/SCAI guidelines to level of evidence A," commented Dr. Mort Kern, Chief of Cardiology for the VA Long Beach Health System and Associate Chief of Cardiology at UC-Irvine Medical Center. "One key hurdle that physicians continuously battle with is the accurate and efficient diagnosis of lesion significance at the time of the procedure. Any improvement to the performance of today’s FFR wires that make assessment of multi-vessel disease lesions easier and faster is a welcome change to physicians."

Press release: Volcano Announces 510(k) Clearance, CE Mark Approval, and First Clinical Use for the PrimeWire PRESTIGE(TM) Pressure Guide Wire…

Volcano Corp…