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Catheter Delivered Aortic Valve from Direct Flow Medical Wins European Clearance (w/video)

by GENE OSTROVSKY on Jan 28, 2013 • 1:32 pm

Having unveiled attractive results of a study on its transcatheter aortic valve, Direct Flow Medical (Santa Rosa, CA) has just announced CE Mark approval for the device. The polymer frame prosthesis sits on top of the diseased natural valve with its inflatable rings guaranteeing contact along the perimeter.

Since the new valve only uses physical pressure from the inflatable rings to hold on, it can be repositioned at any time or removed completely if necessary.

Here’s more about the valve from its product page:

The bovine pericardial leaflets are attached to an inflatable polyester fabric cuff which conforms to the native aortic valve annulus and left ventricular outflow tract to form a seal to minimize the potential of paravalvular leak. The Bioprosthesis is designed with independently inflatable ventricular and aortic rings, which encircle and capture the native valve annulus to provide positive axial anchoring of the device. Inflation of the cuff with a saline and contrast solution renders the valve immediately functional and permits fluoroscopic visualization. Before final deployment, the saline and contrast mixture is exchanged under pressure, maintaining cuff shape and position, with a solidifying Polymer that hardens to form the permanent support structure.

 

WATCH VIDEO 

Direct Flow Medical: Transcatheter Aortic Valve

 

Flashback: Direct Flow Medical Transcatheter Aortic Valve Does Well in Clinical Study

Product page: Direct Flow Medical Transcatheter Aortic Valve System…

SOURCE:

http://www.medgadget.com/2013/01/catheter-delivered-aortic-valve-from-direct-flow-medical-wins-european-clearance-wvideo.html?

http://www.medgadget.com/2013/01/catheter-delivered-aortic-valve-from-direct-flow-medical-wins-european-clearance-wvideo.html?goback=%2Egde_4346921_member_205701983%2Egmr_675087%2Eanp_675087_1359500095698_1%2Egmr_675087%2Egde_675087_member_208816811%2Egmr_675087

Other articles related to this topics were published on this Open Access Online Scientific Journal, include the following:

August 7, 2012 – Transcatheter Aortic Valve Implantation (TAVI): risk for stroke and suitability for surgery

https://pharmaceuticalintelligence.com/2012/08/07/transcatheter-aortic-valve-implantation-tavi-risky-and-costly-2/

August 2, 2012 – Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly

https://pharmaceuticalintelligence.com/2012/08/02/transcatheter-aortic-valve-implantation-tavi-risky-and-costly/

June 4, 2012 – Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment https://pharmaceuticalintelligence.com/2012/06/04/investigational-devices-edwards-sapien-transcatheter-heart-valve/

June 10, 2012 — Investigational Devices: Edwards Sapien Transcatheter Aortic Heart Valve Replacement Transfemoral Deployment https://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/