Direct Flow Medical Wins European Clearance for Catheter Delivered Aortic Valve
Reporter: Aviva Lev-Ari, PhD, RN
UPDATED on 7/15/2018
Direct Flow Medical, which markets a CE-marked transcatheter aortic valve implantation (TAVI) device, has closed after funding from a Chinese pharmaceutical company did not come through. According to newspaper The Press Democrat, all 250 company’s employees have been made redundant and it officially ceased trading on 30 November.
The paper reports that Direct Flow’s former president and chief executive officer Dan Lemaitre, in a phone interview, told them the company had expected an influx of funding from a Chinese pharmaceutical company on 18 November but the deal collapsed two days before the money was scheduled to arrive. Lemaitre said this was because “the terms of which were changed dramatically in a very unacceptable fashion.”
The Press Democrat claims that the 12-year-old company had no other options and its lender—PDL BioPharma Inc—refused to extend the US$65 million funding arrangement it had with Direct Flow for the past three years and foreclosed upon the business.
SOURCE
TAVI company Direct Flow Medical closes after failing to secure funding
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:
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
August 2, 2012 – Transcatheter Aortic Valve Implantation (TAVI): Risky and Costly
June 4, 2012 – Investigational Devices: Edwards Sapien Transcatheter Aortic Valve Transapical Deployment http://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 http://pharmaceuticalintelligence.com/2012/06/10/investigational-devices-edwards-sapien-transcatheter-aortic-heart-valve-replacement-transfemoral-deployment/
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