Companies

Medtronic, Inc. has announced the start of PROMISE, the first ever, large-scale study comparing the effectiveness of its neurostimulation therapy plus optimal medical management to optimal medical management alone in failed back surgery patients.

Medtronic, Inc. has announced the CE mark and international launch of its Complete SE (self-expanding) vascular stent for use in the lower extremities, specifically the superficial femoral arteries and proximal popliteal arteries.

Cyberonics, Inc. says Bruce H. KenKnight , Ph.D., has joined the company as its Vice President, Emerging Therapies. Dr. KenKnight will lead all of the company’s emerging therapies programs, including the current clinical evaluation of Autonomic Regulation Therapy.

Vascular device company AngioDynamics has exercised its option to purchase certain assets of Microsulis Medical Ltd. including a leading microwave ablation technology and its worldwide distribution rights.

Bloomberg has reported on the pre-trial testimony of Paul Voorhorst, a DePuy biostatistician, as a preamble to proceedings in the case of Loren Kransky vs J&J (DePuy), for which the jury sits tomorrow (Friday 25th January). In it, previously unseen documents suggest that the company’s own estimates of failure rate for some of its metal-on-metal hip prostheses are now as high as 37%, significantly higher than the 12 or 13% cited in the original recall notices.

Covidien has gained CE Mark approval for its EverFlex™ Self-expanding Peripheral Stent with Entrust™ Delivery System which it says is designed to allow physicians to consistently place stents in the desired location with accuracy and ease.

Today sees J&J’s annual business review at which the company says it will lay out its strategic ideas for growth. Its press release offers few surprises and could be summarised as “more of the same”, which is no bad thing looking at the financial results for 2012.

St.Jude didn’t miss the opportunity to tout its news at the recent Boston AF symposium last week. Not the least of its offerings was a newly CE marked cardiac catheter which is claimed to offer a new level of manou…maneu…ma… oh it handles really well, OK?

Zimmer has received FDA 510(k) clearance to market iASSIST™ Knee, the Personalized Guidance System™ for knee replacement procedures. Zimmer says its device provides simple, intuitive and accurate intraoperative feedback and alignment validation to surgeons during joint replacement procedures, eliminating the need for bulky capital equipment.

Occlusion of the Left Atrial Appendage has become a recognised preventative measure in the AF patient, this anatomical feature being the source of the majority of clots. Now occlusion has been made easier with the CE marking and introduction of a next generation device from St.Jude Medical, Inc.

A surgeon in Canada has employed a firm of lawyers to help him in a breach of contract dispute with NuVasive. In what looks like an unusual strategic move (at least to us Europeans The lawyers have issued a press release which looks designed to draw all of our attention to the alleged breach. Surely this stuff should stay in the courtroom, no?

The first patient has been treated in the Boston Scientific’s ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Temperature Ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation. This international, multi-center study will include up to 472 patients at 33 sites in the United States, Europe and Asia-Pacific.

Covidien has announced the commercial launch of the OneShot™ Renal Denervation System, an over the wire balloon-based irrigated catheter technology for the treatment of high blood pressure or hypertension.

Cardiac device and remote monitoring company Biotronik, has gained U.S. FDA approval to commence its ProMRI® clinical trial under an Investigational Device Exemption (IDE). Recruitment is underway.

St. Jude Medical, Inc. has gained U.S. FDA approval for its next-generation Merlin.net™ Patient Care Network (PCN), a secure, Internet-based remote care system for patients with implanted medical devices.

Whatever the reasons Given Imaging had for exploring a sale, the Israeli manufacturer of the famous Pill-cam has decided the time isn’t right to progress the idea. So for now it’s back to the job of dominating its therapeutic niche through more development, more acquisitions and hopefully more regulatory approvals.