Archive for the 'Surgical Instruments' Category

NiTi Surgical Solutions Introduces Investigational Bowel Anastomosis Device

NiTi Surgical SolutionsNiTi 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.

FDA approves Collagen Dental Membrane

CollagenCollagen 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 AtriClip System gets CE Mark approval

AtricureAtriCure 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.

FDA reconsidering approval of ReGen knee device

RegenThe 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.

FDA clears Covidien Leak Compensation software

covidienCovidien 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.

FDA Okays Bryan Cervical Disc

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 Launches New, Bioinert Surgical Hemostats

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.

Pioneer Surgical’s nanOss cervical cage implanted successfully

Pioneer Surgical Technology, Inc. has announced that the human implantation of its nanOss(TM)- Cervical cage has been carried out successfully. Designed to work as a bone, the device was used for standard cervical fusion surgeries performed at hospitals in China. The biologic inter-body spacer was used in combination with routine rigid fixation. The nanOss technology makes it two times stronger than PEEK cages.

Vertiflex launches Silverbolt™ Plus

VertiFlex® Inc. has launched its Silverbolt™ Plus, a for posterior lumbar fixation solution. The system is designed to help surgeons in various types of approaches – open, mini-open and percutaneous, for fixation of the lumbar spine. The single instrument set, said Earl Fender, CEO, Vertiflex, will support a variety of surgical applications such as percutaneous dynamic stabilization and percutaneous delivery of vertebral levels. The company develops motion preservation technologies and minimally invasive solutions for the treatment of spine disorders.

MCS Medical introduces non invasive solution for DVT

Israeli company MCS Medical Compression Systems has come up with a non-invasive device, ActiveCare+SFT, which supports blood circulation in the limbs, thereby preventing deep vein thrombosis (DVT). Formation of blood clots deep inside the body can have dangerous consequences. Thus, it has become a major concern for the surgeons. Anticoagulants prevent clot formation, but increase bleeding risk. The mobile system has compression sleeves which can be wrapped around the foot of the patient during the surgery. Identifying the blood flow in the veins of the patient, the device synchronizes its functioning to the natural rhythm.

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