Approval/Clearance

Teleflex Incorporated has announced that its Rusch® EZ-Blocker™ Disposable Endobronchial Blocker has received FDA 510(k) clearance. The product is designed to allow for safer and easier lung isolation and one lung ventilation.

Spinal device company Baxano sees its minimally invasive spinal fusion technology platform expand with the FDA’s clearance of its iO-Tome™ instrument for precise facet joint removal.

With a focus on developing lesion specific solutions for peripheral artery disease, Medtronic, Inc. has announced the U.S. and international launches of the Amphirion Plus Percutaneous Transluminal Angioplasty (PTA) Catheter for the interventional treatment of atherosclerotically narrowed or occluded leg arteries below the knee.

Cook Medical made the Zilver Vena™ Venous Self-Expanding Stent available to physicians across Canada at last week’s 2012 Annual Meeting of the Canadian Society for Vascular Surgery. Designed to restore blood flow in obstructed iliofemoral veins, Cook says the purpose-designed stent provides physicians with a tool designed specifically for the task.

Volcano Corporation a leading developer and manufacturer of precision guided therapy tools designed to enhance the diagnosis and treatment of coronary and peripheral vascular disease, said today it has received clearance to market its new Visions® PV .035 Digital IVUS Catheter in both the US and Europe. The new intravascular ultrasound catheter is designed to image large vessels and facilitate the use of less iodinated contrast in endovascular procedures.

Avery Dennison Medical Solutions has announced that it has received 510(k) clearance from the U.S. FDA for its new Chlorhexidine Gluconate (CHG) transparent film dressing, known as BeneHold™ CHG Transparent Film Dressing.

Covidien has announced U.S. FDA 510(k) clearance and CE Mark approval for its next generation of Nellcor™ Bedside Respiratory Patient Monitoring system.

Last week the U.S. FDA issued its Pre-market Approval (PMA) for the Globus SECURE®-C Artificial Cervical Disc. Now the agency has issued its consumer information on the product which the company says outperforms anterior cervical discectomy and fusion.

Echometrix LLC has announced that it has received U.S. FDA clearance to market its EchoSoft™ ultrasound technology, which the company claims provides a new level of information from diagnostic ultrasound tests.

Sunshine Heart Inc. has announced that it has received conditional approval from the FDA for an Investigational Device Exemption for its flagship C-Pulse extra-aortic, counter-pulsation, heart assist device.

It’s looking like Boston Scientific Week with more news about launches or approvals. The FDA has approved Boston’s S-ICD® System, which we seem to remember triggers a big fat earn-out payment to Cameron Health following its acquisition earlier this year.

Boston Scientific Corporation (NYSE: BSX) has received U.S. Food and Drug Administration clearance for the Emerge™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Balloon Dilatation Catheter and has begun marketing the device in the United States. The Emerge Catheter is a next-generation pre-dilatation balloon catheter designed specifically to offer exceptional deliverability for physicians to address challenging lesions in coronary arteries. Both the Monorail® and Over-The-Wire (OTW) options are available. The Emerge Catheter has been commercially available in CE Mark countries since earlier this year.
PR Newswire (http://s.tt/1ov7B)

Bolton Medical has announced the FDA’s approval of its Relay® Thoracic Stent-Graft with Plus Delivery System. The device is designed to address the needs of physicians performing minimally invasive surgery for thoracic aortic aneurysms and penetrating ulcers.

Amedica Corporation, a spinal and reconstructive medical device manufacturer, announced today it has received FDA 510(k) clearance to legally market a second generation family of cervical and lumbar interbody fusion devices manufactured with the company’s proprietary Silicon Nitride biomaterial. The product offers design enhancements the company says will allow surgeons to perform minimally invasive and lumbar lateral interbody fusion approaches.

New Jersey device company Precision Spine, Inc. has announced that it has received 510(k) clearance from the FDA its ReForm Pedicle Screw System. Physician/Developer says it will increase efficiency of application and ease ergonomic use.

Medtronic announces CE mark for CoreValve® Evolut™, incorporating features designed for optimal fit. With the new 23mm iteration, Medtronic claims its CoreValve family treats the broadest range of patient valve sizes.