• Immersion Medical (San Jose, California) has introduced the LaparoscopyVR Surgical Simulation System. The LapVR system, including hardware and software designed by Immersion, comes in a self-contained cart and provides a tool to assist in training of minimally invasive laparoscopic procedures. The base laparoscopy surgical simulator includes an essential skills module with 15 skill exercises, a laparoscopic cholecystectomy (LapChole) module with 18 cases, and an administration module. The essential skills module includes unique exercises for developing camera navigation, cutting, clipping, adhesiolysis, and hand transfer skills. The LapChole module provides a simulated environment for removal of the gall bladder. Immersion makes digital touch technology, and Immersion Medical makes computer-based surgical simulation training systems.
• Innocoll (Ashburn, Virginia) said that its subsidiary, Innocoll Technologies , has filed an investigational new drug (IND) application for its CollaRx gentamicin surgical implant, which is under development for the prevention of surgical site infections as an adjunct to standard infection prophylaxis. This is the third IND that Innocoll has filed in the last 6 months following similar submissions for the topical use of CollaRx gentamicin in the treatment of infected diabetic foot ulcers and for its CollaRx bupivacaine implant in the management of post-operative pain, both of which are already approved. CollaRx is Innocoll’s lead technology platform for the site specific targeted delivery of a wide variety of drugs with particular emphasis on antibiotics and anesthetics. The CollaRx technology also forms the basis of Innocoll’s lead product, Gentamicin surgical implant, a biodegradable leave-behind implant indicated for the treatment and prevention of post-surgical acquired infection in both hard and soft tissues. Innocoll is a privately held pharmaceutical company.
• MIV Therapeutics (Vancouver, British Columbia) reported the first human implantation of a hydroxyapatite-coated stent and the launch of a pilot test. The trial will evaluate the safety and efficacy of MIVT’s polymer-free nanoscale microporous hydroxyapatite drug-eluting stent (DES) for the treatment of single de novo lesions in native coronary arteries. MIVT has developed polymer-free, nanoscale microporous HAp DES that uses the company’s GenX coronary stent system coated with one of the company’s proprietary polymer-free systems that is 700 nanometers thin. It says that this ultra-thin coating, designed to protect surrounding tissue from harmful interactions with bare metal stents, is derived from an organic material called hydroxyapatite which MIVT says has demonstrated safety and biocompatibility in in vivo animal studies. It believes its coatings are applicable to a range of other implantable devices. MIVT makes biocompatible coatings and drug delivery systems for cardiovascular stents and implantable devices.
• Misonix (Farmingdale, New York), reported the acceleration of patient enrollment relating to the FDA clinical trials for the Sonablate 500, a medical device using high intensity focused ultrasound (HIFU) for non-invasive treatment of prostate cancer. The Sonablate 500 is approved by the FDA as an investigational device for clinical trials in the U.S. With the SB500 being used in 6,000 treatments in over 100 clinics in six years, interest in and usage of the HIFU medical device for prostate cancer treatment is gaining momentum. Misonix makes products for treatment of cancer.
• Swissray International (Elizabeth, New Jersey) reported receiving FDA clearance for its ddRCompact sSeries of DR systems. The system was specifically designed to meet the needs of certain markets such as orthopedics, smaller hospitals, imaging centers, veterinary, chiropractic, and all emerging countries requiring a lower cost DR system with high image quality. The ddRCompact series offers exceptional image quality at low radiation dose. It comes with Swissray’s APS (automated positioning system) for fastest, most convenient and precise patient positioning. It also features autostitching for orthopedic examinations, proactive remote monitoring and a 99% uptime guarantee. Swissray makes direct digital radiography products.
• Vertebration (Powell, Ohio) reported FDA clearance of the XYcor spinal implant, an expandable device giving surgeons a low-profile solution to the anatomic constraints of minimally invasive surgery. For insertion, the XYcor requires one-half the intradiscal entry point, but once deployed has a footprint comparable to traditional anterior interbody/VBR devices. The XYcor is delivered via a minimal access posterior/posterolateral annulotomy that is no larger than that used for a standard microdiscectomy. The implant is designed to restore and maintain biomechanical integrity throughout the thoracolumbar spine following vertebrectomy or corpectomy for patients with spinal tumors or fractures. The implant, together with supplemental rigid internal fixation, provides anterior, middle and posterior column support both immediately after surgery and for prolonged periods in the absence of bone fusion. The implant is a cross-limbed, expandable vertebral body replacement device manufactured from surgical grade titanium. Vertebration makes minimally invasive spinal implant systems.