ATS Medical, Inc. has announced it has received U.S. Food and Drug Administration (FDA) approval for the ATS 3f(R) Aortic Bioprosthesis. This is the Company’s first entry into the $400-plus Million U.S. tissue valve market. Based on the precept that ‘Form Follows Function’, the ATS 3f Aortic Bioprosthesis is a revolutionary next generation stentless pericardial aortic tissue valve that is unlike any other replacement valve. The product is based on a proprietary valve design that reproduces the functional characteristics of the native aortic valve.

Dune Medical Devices, Ltd. has launched a crucial clinical trial of the MarginProbe™, the company’s intra-operative, real-time, positive margin detection system. The launch follows the investigational device exemption (IDE) approval from the U.S. Food and Drug Administration of its protocol during surgery for breast cancer. To determine how malignant the tumor margins are, the MarginProbe system uses Radio Frequency Spectroscopy to characterize breast tissue. A controlled trial concluded that application of the probe by surgeons during lumpectomy reduced the need for repeat surgeries by 56%.

Lutronic, Inc.’s. eCO2 system has received regulatory clearance from the U.S. Food and Drug Administration. Based on the Controlled Chaos Technology (CCT), this laser offers a safe treatment of deep ablative indications like resurfacing and coagulation of soft tissue, textural irregularities and pigmented lesions. Also, the system is easy to use and has reduced pain and discomfort to the patients. With numerous patents pending, the eCO2 has added features like a software that can select between a random or sequential beam pattern etc.

The U.S. Food and Drug Administration has approved BSD Medical Corporation’s microwave surgical device MicroThermx, which is designed for use by surgeons to ablate soft tissue. This is used as a treatment for coronary artery disease by restoring blood flow to the heart. It is a moveable device that includes a computer, microwave generator and disposable applicators. The company has made a point that after the sale of system, use of disposable parts would give the company a source of ongoing revenue.

The U.S. Food and Drug Administration has granted PEAK Surgical, Inc 510(k) clearance to market its PEAK(R) Surgery System for use in general surgery. The medical device company has developed this new tissue dissection system based on a proprietary technology. It combines the PULSAR Generator, which supplies pulsed plasma radiofrequency energy, with the PEAK PlasmaBlade 4.0, a low-temperature surgical cutting and coagulation tool. This will make the cutting process more accurate and control bleeding. The new surgery system will be available in the market by next month.

Atrium Medical Corporation has obtained FDA 510(K) approval for two new Omega 3 surgical mesh products; C-QUR Edge V-Patch and C-QUR Lite V-Patch. These new products are indicated for use in the surgical repair and reinforcement of soft tissue, including hernia repair. This novel technology combines Atrium’s ProLite Ultra(TM) polypropylene surgical mesh with a proprietary, pharmaceutical grade Omega 3 fatty acid bio-absorbable gel coating.

St. Jude Medical Inc.has received approval from U.S. Food and Drug Administration (FDA) and European CE Mark for its Strada Carotid Guiding Sheath. The equipment is a flexible tube available in 80 and 90 cm working lengths through which physicians can deliver balloon catheters, stents and other tools to open blockages in the carotid arteries.

Covidien Ltd. has received approval from the FDA to market a surgery kit for use in laparoscopic procedures. Covidien’s SILS Procedure Kits can be used by surgeons to perform the procedures through a single incision through a patient’s belly button. The kit is set for launch this summer.

Arbios Systems Inc. has received approval from the FDA for an investigational device exemption to begin the pivotal clinical trial for its liver-assist device, SEPET, for purifying blood in acutely ill patients with chronic liver disease. When a patient’s blood is passed through the device containing microporous, hollow fibers, blood plasma components are cleansed of harmful impurities. These impurities would otherwise accumulate in the patient’s bloodstream during liver failure, causing hypotension, increasing the risk of sepsis development and accelerating damage to the liver, lungs and other organs.

Vascular Insights LLC has achieved 510(k) clearance from the FDA to market its ClariVein infusion catheter. The catheter infuses physician-specified agents in the peripheral vasculature. It contains a rotating wire driven by a motor that enhances fluid dispersion in the treatment area.