Regulatory

It’s taken the illegal actions of a rogue implant manufacturer to catalyse what looks increasingly like a radical reform of the cosmetic “surgery” industry in the UK. Lots of sensible recommendations from the aesthetic surgical fraternity, but weren’t these obvious deficiencies?

UK regulatory agency the MHRA has issued a device alert relating to the MicroPace 4580 from Pace Medical, distributed in the UK by APC Cardiovascular. Full details of the alert and required actions can be found here.

Lombard Medical Technologies PLC, is confident it will jump the final hurdles as it gains written feedback from the U.S. FDA on the PMA application for Aorfix™, the Company’s flexible stent graft for the endovascular repair of abdominal aortic aneurysms.

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)

Gimme a P, Gimme an M, Gimme an A. What do you get? Well, not quite a PMA, but the end result might look mighty like it by the time it hits the streets. Not a bad thing though, and there’s lots of really sensible and even pragmatic stuff in the new device regs, especially the re-hash of notified body rules.