Physician Resources
New Products/Product News
Am J Orthop. 2009 February;38(2):101
Expanded Indications for Surgery System
| PEAK Surgical, Inc., a medical device company that has developed a new tissue-dissection system based on a proprietary technology, announced that the US Food and Drug Administration (FDA) has granted the company 510(k) clearance to market its PEAK® Surgery System for cutting and coagulation of soft tissue during plastic and reconstructive, ear, nose, and throat (ENT), gynecologic, orthopedic, arthroscopic, spinal, and neurological surgical procedures. The PEAK Surgery System, which received FDA clearance for use in general surgery in July 2008, includes the PEAK PlasmaBlade™ family of disposable surgical cutting and coagulation devices. The PlasmaBlade tissue-dissection devices are used in conjunction with PEAK's PULSAR™ Generator, which provides pulsed plasma radiofrequency energy to the PlasmaBlade to incise tissue and control bleeding. The company notes that the PlasmaBlade offers the exacting control of a scalpel and the coagulation of traditional electrosurgery without causing extensive collateral damage. Since FDA clearance, surgeons in the United States have used the PlasmaBlade in nearly 350 surgical procedures, including in general, gynecologic, cardiothoracic, and plastic and reconstructive surgeries. For more information, contact PEAK Surgical, Inc. |
Dual Threaded Anchor System
| DePuy Mitek, Inc., has announced the launch of the HEALIX™ BR Dual Threaded Anchor System, the first suture anchor for arthroscopic rotator cuff repair made with the company’s proprietary BIOCRYL® RAPIDE™ biocomposite material. Shown in pre-clinical trials to resorb and promote bone formation within the implant profile,1 the biocomposite material, exclusive to DePuy Mitek products, has more than 4 years of clinical success in more than 100,000 patients, according to the company. HEALIX™ BR is an extension of the successful HEALIX™ PEEK family of anchors. Both anchors are designed to independently engage cortical and cancellous bone, maximizing pull-out strength and potentially minimizing re-tears. HEALIX anchors are available in 3 sizes (4.5-mm, 5.5-mm, and 6.5-mm) to address a wide variety of surgical techniques, and may be pre-loaded with ORTHOCORD, the company’s high-strength suture. BIOCRYL RAPIDE has shown, in preclinical models, marked absorption and a proliferation of bone cells after 18 months, with near total absorption in about 24 months.1 For more information, contact DePuy Mitek, Inc. 1. Pre-clinical study. Data on file at DePuy Mitek, Inc. |
Posterior Fixation System