Surgical Product Guide

CryoLife Receives FDA Approval to Begin U.S. Clinical Trial for BioFoam(R)

Tony Black — Fri, 06 Nov 2009 11:23:38 +0000

CryoLife, Inc. has announced that the FDA has approved the company’s Investigational Device Exemption to conduct a human clinical trial for its BioFoam® Surgical Matrix protein hydrogel technology. BioFoam will be used to seal liver parenchymal tissue when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The approved IDE is for a prospective, multicenter, randomized feasibility study evaluating safety outcomes of BioFoam as compared to a standard topical hemostatic agent.

NiTi Surgical Solutions Introduces Investigational Bowel Anastomosis Device

Tony Black — Fri, 30 Oct 2009 15:06:13 +0000

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.

FDA approves Collagen Dental Membrane

Tony Black — Fri, 23 Oct 2009 18:24:15 +0000

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.

Bovie laparoscopic SEER device approved

Tony Black — Fri, 16 Oct 2009 03:51:48 +0000

Bovie Medical Corp has received clearance to sell a device that cuts and reseals tissue in kidney surgeries. The FDA has approved market of Bovie’s laparoscopic SEER device, which is used for cutting and coagulating soft tissue. It is intended to be used in partial removal of kidneys. Bovie said the laparoscopic SEER, or Saline Enhance Electrosurgical Resection, device is an extension a line the company launched earlier this year.

AtriCure AtriClip System gets CE Mark approval

Tony Black — Fri, 09 Oct 2009 05:17:04 +0000

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.

Covidien receives FDA clearance for Mallinckrodt TaperGuard Evac endotracheal tube

Tony Black — Thu, 01 Oct 2009 05:15:35 +0000

Covidien has received clearance from the FDA to market a medical device, called the Mallinckrodt TaperGuard Evac endotracheal tube, created to reduce the risk of postsurgical complications caused by the aspiration of fluids into the lungs. Although complications from pulmonary aspiration are rare, the consequences can be severe, Covidien said.

FDA reconsidering approval of ReGen knee device

Tony Black — Fri, 25 Sep 2009 04:21:11 +0000

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.

Nucleus 5 System implant for hearing impaired approved

Tony Black — Fri, 18 Sep 2009 04:19:02 +0000

The FDA has approved Cochlear’s Nucleus 5 System for adults and children with severe-to-profound hearing loss. The Nucleus 5 System is the only one of its kind on the market today that offers the smallest, most water resistant sound processor, the thinnest titanium cochlear implant, two-way remote assistant, SmartSound((TM)) 2 technology and AutoPhone (TM) capability.

Study: LUNA not effective for alleviating chronic pelvic pain

Tony Black — Fri, 11 Sep 2009 07:11:38 +0000

According to a study published in the September 2 issue of JAMA laparoscopic uterosacral nerve ablation (LUNA) does not result in the improvements in chronic pelvic pain, painful menstruation, painful sexual intercourse or quality of life, when compared with laparoscopic surgery that does not interrupt pelvic nerve connections. The study was conducted by a team from Birmingham Women’s Hospital, University of Birmingham.

Impact of obesity surgery extends to next generation

Tony Black — Fri, 04 Sep 2009 13:06:51 +0000

A new study shows that children born to women who have achieved drastic weight loss through stomach surgery are healthier than children born to severely obese moms. The findings suggest that obesity creates an unhealthy environment for a fetus that has ramifications later on, scientists report in the November Journal of Clinical Endocrinology & Metabolism. Dana Dabelea, a physician and epidemiologist at the University of Colorado–Denver and the Colorado School of Public Health in Aurora said “This is the first proof that exposure to obesity in utero is associated with long-term effects.”