Medtronic

Medtronic, Inc. has announced the CE Mark and the European launch of its ReDuX™ Plier, a new instrument specially designed … continue reading “Newly CE Marked Medtronic ReDuX™ Plier Facilitates Osteotomies in Spinal Deformity Surgeries”

Medtronic, Inc. is trumpeting with new data on its Endurant AAA stent graft, which it says demonstrates durable clinical performance through three years of patient follow-up in the endovascular repair of Abdominal Aortic Aneurysms.

Medtronic, Inc. tells us that that enough patients have been enrolled in its clinical studies of the IN.PACT Admiral drug-eluting balloon to support the company’s U.S. regulatory approval submission of the novel angioplasty device, which is designed to treat atherosclerotic lesions in the superficial femoral artery.

Medtronic, Inc. is showcasing its newly approved stent graft at this weekend’s Vascular Annual Meeting, taking place in San Francisco. The company has gained FDA approval for the Endurant II Aorto-Uni-Iliac (AUI) Stent Graft System and the FDA 510(k) clearance for the Sentrant Introducer Sheath

Medtronic, Inc. has received CE Mark approval for valve-in-valve (VIV) procedures using the CoreValve® and CoreValve® Evolut™ transcatheter aortic valve implantation (TAVI) systems in degenerated bioprosthetic surgical aortic valves.

Medtronic, Inc. has announced it has finished randomizing Symplicity HTN-3, the company’s pivotal U.S. clinical trial of the Symplicity™ renal denervation system for treatment-resistant hypertension. The company is hoping this is a landmark in its progress towards U.S. approval.

Two new devices from the Medtronic ICD/CRT-D stable have gained FDA’s approval. These are the Viva®portfolio of cardiac resynchronization therapy with defibrillation (CRT-D) devices, and the Evera® portfolio of implantable cardioverter-defibrillators (ICD).

Medtronic’s Urgent Medical Device Correction notification relating to the use of potential damage associated with its Deep Brain Stimulation (DBS) lead kits and dystonia therapy kits has now been classified by the FDA as a Class I Recall, its most serious category.

The first implants of a novel aortic stent graft for use where aneurysms include sidebranches, have been performed under a new FDA early feasibility pilot program, designed to encourage more early-stage clinical research on new medical devices.

This weekend (April 6-9) sees the 35th running of the Charing Cross Vascular Symposium in London. Medtronic has just received CE mark approval for its new AAA stent graft introducer sheath and will be showcasing it among its other offerings at the event.

Medtronic, Inc. has gained U.S. FDA 510(k) clearance of its new Affinity Fusion® oxygenation system. The system is designed to serve as a patient’s lungs by oxygenating and removing carbon dioxide from blood during various open-heart surgical procedures.

Eu regulators have allowed Medtronic to claim one month DAPT requirement in new labelling for its Resolute Integrity drug eluting stent. A timely press release in view of this weekend’s ACC meeting.

Medtronic acquired CoreValve after Edwards Lifesciences had started proceedings against it for patent infringement. Now, years later, Medtronic has been forced to pay damages for infringement. No doubt this was accounted for in the original purchase agreement, but speculation remains whether CoreValve will ever reach the U.S. market.

Medtronic says its newly CE marked quadripolar leads provide options for physicians to deliver CRT optimally and efficiently. A global clinical study has started enrolling patients in an effort to back up these claims.

Forbes is not exactly a medtech publication. It’s fascinating therefore to see it covering the story of how an investigator … continue reading “FDA Warning For CoreValve Investigator Hits The News”

Transcatheter heart valves hit our news pages seemingly every week. Today its the turn of Medtronic with the news that its Engager valve, optimised for transapical delivery, has gained CE mark approval, based on solid looking numbers from its pivotal multi-center study.