Cardio

Positive long-term results for Abbott’s Absorb™ Bioresorbable Vascular Scaffold (BVS) Trial were presented at the 62nd Annual Scientific Session of the American College of Cardiology (ACC) in San Francisco. Three year results from 101 patients show cardiac event rate comparable with metal stents, but improved vasomotion and late lumen gain.

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.

Vital Images, Inc., a Toshiba Medical Systems Group Company and leading provider of advanced visualization and analysis solutions for healthcare providers, has received FDA 510(k) clearance for its CT TAVR (Transcatheter Aortic Valve Replacement) planning application.

Are these big medical specialty congresses meant to be showcases for technology? If so, stick highlights package on daytime TV and let’s see who watches. I would.

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.

Intellectual property and regulatory review periods are connected because of a recognition that a patent is only valuable when a product is on the market. So, rules exist that enable a patent extension to be granted by (of all agencies), the FDA, which correlate to the regulatory review time spent. Bottom line: Edwards Lifesciences wants to extend its Sapien patent by almost five years.

Tenaxis Medical®, Inc. Receives FDA Approval for its ArterX® Surgical Sealant (via PR Newswire) MOUNTAIN VIEW, Calif., March 4, 2013 … continue reading “FDA Approval For Tenaxis Medical® ArterX® Surgical Sealant”

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.

CircuLite’s Synergy Minimally-Invasive heart pump is designed to reverse heart failure, thereby filling a treatment gap for ambulatory Chronic Heart Failure patients. The company is hoping a U.S. IDE study will edge the device closer to approval.

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.

VentriPoint Diagnostics has clever dot-based software that can quickly attain right ventricle dimensional data for comparison with a library of heart conditions, thereby assessing patient status. It’s system is already CE marked and is looking close to FDA clearance following the agency’s nod that everything looks in order.