Clinical Studies/Trials

Eight-year study confirms PFO closure was superior to medical therapy alone in reducing risk of recurrent stroke in prespecified per-protocol and as-treated cohorts.

Newly published data indicates St. Jude Medical Trifecta Heart Valve closely resembles the hemodynamic performance of a natural, healthy heart valve

FDA’s reading material, issued in advance of today’s PMA review meeting are not recommending the approval of the MitraClip implantable heart device, citing a lack of “valid scientific evidence” of safety and effectiveness. And a lack of comparator group.

In short Surgical adhesive and sealant company, Cohera Medical, Inc.® , has announced that it has received approval to begin … continue reading “European Clinical Trial Of New Bowel Sealant To Commence”

Transcatheter heart valve company Direct Flow Medical®, Inc., has been trumpeting the DISCOVER Trial results presented Sunday at the American College of Cardiology (ACC) Annual Meeting. Patients treated with the Direct Flow Medical® Transcatheter Aortic Valve System achieved excellent survivability and sustained hemodynamic improvements with minimal occurrence of aortic regurgitation at six months.

Two interesting clinical trials were reported at ACC Scientific Sessions last weekend. Firstly Edwards Lifesciences’ Sapien XT seemed to offer improvements in rate of vascular events compared with its big brother. Also, in the pivotal PARTNER study of Sapien, results were comparable with conventional surgery despite ongoing high comparative incidence of paravalvular leakage.

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.

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.

We’ve heard it all quite often now: Renal denervation could have therapeutic uses beyond “just” blood pressure reduction. Could it even be used to treat diabetes or sleep apnea? A newly published study, reported in eCardiology News suggests the answer may be yes.

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.

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”