Surgical Product Guide

BOSS submitted for the FDA approval

Tony Black — Fri, 17 Jul 2009 18:18:57 +0000

Bovie Medical Corp has applied for pre-market clearance from the FDA for a device designed to be used in orthopedic surgeries. The device, named BOSS, primarily will be targeted toward orthopedic hip and knee reconstruction surgeries. More than 1.3 million such procedures are performed in the US annually and the market is growing due to a move active and aging population.

Study depicts 98.8% survival rate through laparoscopy-assisted surgery

Tony Black — Fri, 10 Jul 2009 05:01:25 +0000

A study published in the June 2009 issue of the Archives of Surgery depicted that laparoscopy-assisted surgery for early gastric cancer resulted in a 98.8% three-year overall survival rate in patients with early gastric cancer. Laparoscopic gastrectomy is a minimally invasive surgical procedure, in contrast with the total removal of the lymph nodes in traditional treatment. In Laparoscopic gastrectomy, a surgeon removes the stomach through a lighted tube, eliminating the need for large surgical incisions and possibly reducing the risk of infection, healing complications, pain and blood loss.

FDA Okays Bryan Cervical Disc

Tony Black — Fri, 03 Jul 2009 05:03:04 +0000

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.

PEAK Surgical Receives 510(k) Clearance To Market PEAK(R) Surgery System

Tony Black — Fri, 02 Jan 2009 13:36:44 +0000

PEAK Surgical, Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its PEAK(R) Surgery System for cutting and coagulation of soft tissue during plastic and reconstructive, ENT (ear, nose and throat), gynecologic, orthopedic, arthroscopic, spinal and neurological surgical procedures. The company also announced that it has initiated a series of clinical studies, called the PRECISE Studies (Pulsed Plasma Radiofrequency Energy to ReduCe Thermal Injury and Improve Surgical HEaling), to evaluate the use of the PEAK Surgery System in plastic, gynecologic and oncologic surgery.

Covidien Launches RapidVac(TM) Smoke Evacuator

Tony Black — Thu, 18 Dec 2008 11:49:09 +0000

Covidien has announced the global launch of the RapidVac(TM) Smoke Evacuator System — a powerful, efficient device that quietly filters airborne contaminants from the operating room environment. The System, an advance in effective control of surgical smoke, features an ultra low penetration air (ULPA) filter with 99.9995 percent efficiency at trapping particulate matter as small as 0.12 microns. The device’s maximum air flow - how much air can be filtered through the system - is 30 percent greater than that offered by previous models, but it operates quietly, without contributing to the ambient noise in the O.R.

Starch Medical Launches New, Bioinert Surgical Hemostats

Tony Black — Tue, 09 Dec 2008 07:45:03 +0000

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.

Ophthalmologists At South Nassau Introduce New Cataract Surgery Technology

Tony Black — Tue, 02 Dec 2008 12:37:56 +0000

Ophthalmologists at South Nassau Communities Hospital are using a new micro-incision ophthalmologic surgical system that allows ophthalmologists to perform cataract surgery through a single incision that is 2.2mm or smaller. Traditional, no-stitch cataract surgery requires an incision that is 33 percent larger. In addition to this latest innovation in micro-incision eye surgery, South Nassau ophthalmologists are among the first in the region to use a cataract surgery system that has three different surgical options. This allows them to develop surgical approaches that are tailored to the needs of each patient.

ATS Medical announces FDA approval for the ATS 3f Aortic Bioprosthesis

Tony Black — Wed, 19 Nov 2008 14:55:42 +0000

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.

Research: Fenoldopam mesylate Induces Hypotension in Children Scheduled for Surgery

Tony Black — Mon, 10 Nov 2008 07:36:43 +0000

Researchers from the Stanford University School of Medicine have reported that fenoldopam mesylate, a selective dopamine 1 receptor agonist which is used intravenously for the treatment of hypertension in adults, can also be effective in producing deliberate hypotension in children scheduled to undergo a surgery. The study, according to the lead author, Dr. Gregory Hammer, affects pediatric labeling for fenoldopam and guides practitioners about appropriate intraoperative dosing for deliberate hypotension.

Dune Medical launches a clinical trial of MarginProbe™ system

Tony Black — Wed, 29 Oct 2008 05:35:14 +0000

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%.