Companies

Japan is the first market to offer St.Jude’s next-generation FFR and OCT ILUMIEN OPTIS System for planning of stent placement

Organisers pulled the PREVAIL study into the Watchman Left Atrial Appendage occlusion device from its allotted slot in the late-breakers clinical session, as well as its associated press conference because Boston Scientific broke its embargo by releasing the data early by email.

This year’s ACC Scientific Sessions have been dominated, at least from a headline perspective, by the Left Atrial Appendage. It seems a number of companies are keen to demonstrate their implants can reduce stroke risk by occluding it. St.Jude is one, with its Amplatzer device.

Data from Abbott’s EVEREST II High Surgical Risk cohort evaluating the company’s first-in-class catheter-based MitraClip® System for the treatment of mitral regurgitation were presented at the Annual Scientific Session of the American College of Cardiology in San Francisco over the weekend.

The FDA has so far not approved Boston Scientific’s Watchman Left Atrial appendage closure device. This week’s ACC event in San Francisco sees the first sight of clinical data from the PREVAIL study which may support the theory that the device is an alternative to blood thinning therapy.

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.

Boston Scientific’s PR machine is on top of its game, drawing attention to all the good things that will be presented in the company’s name at this years ACC meeting at the weekend.

Lumbar spine device company TranS1 Inc., has entered into a definitive agreement to acquire Baxano, Inc., a privately-held medical device company that develops solution for restoration of spine function.

Last week we covered the latest news from the J&J transvaginal mesh proceedings. At the time, the jury had awarded … continue reading “J&J Will Appeal New $11M Pelvic Mesh Award”

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”

Here’s an update on the court case currently underway in the U.S. which may prove a bellwether for future proceedings … continue reading “Kransky vs J&J DePuy Trial Closing Remarks”

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.

Covidien has completed patient enrollment in its iliac stent clinical study series. The series is composed of two prospective, multinational, multicenter studies – VISIBILITY Iliac and DURABILITY Iliac.

Medtronic’s new Transcatheter pulmonary valve study, approved by the FDA, represents the first time this new draft guidance has been employed. The result should be a better product, earlier to market, if the klegislation is doing its job.