SafeStitch Medical, Inc. has announced that it has received 510(k) clearance from the FDA to market its AMID StaplerTM in the U.S. with the intended use in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissues, including skin. The AMID Stapler™ is the first surgical stapler designed specifically for use in inguinal hernia repairs.

According to a study published recently in the Journal of Neurosurgery, neurosurgeons at the Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center in Phoenix, Ariz. found that the pen-sized microscope could help them precisely identify where tumor tissue ends and healthy tissue begins. A laser microscope that picks up fluorescently-dyed cells could result in more precise tumor extraction during brain surgery, and streamlined workflows in the operating room.

W.L. Gore and Associates (Gore) has announced that it has received European CE Mark approval for the next generation GORE TAG® Thoracic Endoprosthesis. The device is available in an expanded portfolio of sizes to meet a broad range of patient needs and was engineered to treat multiple etiologies including thoracic aortic aneurysms (TAAs), traumatic aortic transections and thoracic aortic dissections.

NiTi Surgical Solutions showcased new, investigational bowel anastomosis device at the American College of Surgeons (ACS) 95th Annual Clinical Congress. The device, which will be marketed as BowelRing, represents the company`s next advancement in its innovative BioDynamix Anastomosis Technology platform. NiTi`s unique line of products utilizes Nitinol-based elements to press together the ends of resected tissue, enabling natural reconnection and healing after removing a section as part of a surgery.

Collagen Matrix Inc has received the FDA’s 510(k) clearance for its new Collagen Dental Membrane indicated for use in oral surgical procedures involving guided tissue and bone regeneration. This new Collagen Dental Membrane is a non-friable, conformable, resorbable, membrane matrix consisting of highly purified type I and III collagen derived from bovine dermis.

AtriCure Inc, a medical device company and a leader in cardiac surgical ablation systems, gas received CE Mark approval for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion System. The AtriClip System is designed to safely and effectively exclude the left atrial appendage and is being launched in Europe through a phased approach during the fourth quarter. The system was successfully utilized this week in multiple European centers during both open-heart and minimally invasive cardiac procedures.

The FDA is reconsidering the approval of ReGen Biologics Inc’s knee device after an investigation showed that unprecedented industry and Congressional involvement influenced the agency’s decision. Joshua Sharfstein, the agency’s principal deputy commissioner, said, however, that patients who have had Menaflex implanted in their knee need not panic and noted that the device is still on the market. ReGen Chief Executive Gerald Bisbee said in a statement that the report didn’t evaluate the scientific evidence about the device. The company said the product is safe and helps knee-surgery patients recover more quickly.

Covidien received 510(k) clearance from the FDA to market its Leak Compensation software feature for the Puritan Bennett 840™ ventilator system. This option provides continuous levels of mechanical ventilation to patients requiring respiratory support, regardless of the level of gas leakage that might occur in the circuit or past a patient interface device in the clinical setting.

The US Food and Drug Administration (FDA) has approved a novel artificial cervical disc, BRYAN, for the treatment of single-level cervical disc diseases like radiculopathy and/or myelopathy. The titanium-polyurethane disc, developed by Medtronic Inc, is implanted in milled pockets of adjacent vertebral bodies from C3-C7 to substitute a diseased or bulging natural cervical disc.

Starch Medical Inc. has announced the CE approval of its PerClot(TM) Polysaccharide Hemostatic System (PHS) and the StarFoam(TM) Absorbable Polysaccharide Hemostat. Introduction of PerClot(TM) PHS will commence this month in the European Union and other select international markets. The StarFoam(TM) Absorbable Polysaccharide Hemostat will launch during the 2nd quarter, 2009. PerClot(TM) PHS is an absorbable, surgical hemostat composed of Absorbable Modified Polymers (AMP(TM)). AMP(TM) technology incorporates sophisticated, plant-based polymer modification processes that yield biocompatible, polysaccharide particles. There is no thrombin, collagen, or other human or animal components in AMP(TM) particles.