Minimally Invasive Heart Valve Surgery

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RobThatsMe

Well-known member
Joined
Jun 11, 2001
Messages
1,454
Location
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Hi Everyone,

CardioStar has posted this on the Heart Disease Board on WebMD, and thought I would share this here.

Hopefully many new advancements will aid those of us facing valve replacement surgery in the future.

Hope everyone has a happy and safe 4th of July!

Rob



On the minimally invasive heart valve implantation front

Percutaneous Valve Technologies, Inc.

Percutaneous Valve Technologies and 3F Therapeutics to Develop and Supply New Heart Valve Implantation Technology

Lake Forest, CA./Fort Lee, N.J.

June 17, 2002

(Enhanced)

3F Therapeutics, Inc. (3F) of Lake Forest, CA and Percutaneous Valve Technologies, Inc. (PVT) of Fort Lee, NJ, two privately held medical technology companies, announced a series of exclusive agreements intended to support development of new products for LESS INVASIVE heart valve replacement surgeries and related supply agreements.

"PVT is providing an exclusive limited license and will supply to 3F components for cardiac surgery market applications, aimed at the development, qualification and eventual marketing of unique products introducing new approaches to minimally invasive surgical valve replacement," said Walter A. Cuevas, President and CEO of 3F.

"These contributions to 3F's own patented heart valve designs provide our company with a unique opportunity, intended to improve clinical outcomes and ease the workload of the surgeon, substantially advancing current best practices.

Our combination of the PVT and 3F technologies will ASSIST IN AVOIDING COMPLICATIONS associated with cardiopulmonary bypass currently used in all heart valve replacement surgeries, shorten recovery time, and decrease the length of hospital stay," he concluded.

Dr. James L. Cox, prominent cardiothoracic surgeon (CTS) and Chairman and CEO of the World Heart Foundation (WHF) in Washington, D.C. said, "Many open heart surgical procedures have been improved by developing less invasive techniques employing new devices.

The potential seen in the combination of the 3F and PVT technologies with an objective of EVENTUALLY ELIMINATING CARDIOPULMONARY BYPASS (CPB) in valve replacement would be a significant contribution, improving outcomes for many patients and lowering costs."

Under the same agreement, 3F will supply PVT with biological material and manufacturing expertise for PVT's proprietary heart valve replacement program to be used by the Interventional Cardiologist (IC).

"3F has confirmed the market opportunity for PVT's unique technology in the surgical suite, expanding it beyond the patients who will be treated by the cardiologist", said Stanton Rowe, President and CEO of PVT.

----?"We have recently announced the FIRST aortic valve replacement without open heart surgery, a compassionate use of the PVT system in the Cardiology Department in University of Rouen Hospital, by Dr. Alain Cribier, one of the leading interventional cardiologists in France.

With the 3F agreement, PVT will continue its focus on cardiology applications while 3F will develop surgical applications; as these are the respective areas of our companies' expertise."

There will be over 300,000 heart valve replacement surgeries performed in 2002. This translates to a market of $825 million, and expected growth at 5% per year.

Further acceleration of this growth, in both the rates of implantation (new patient populations) and the potential device revenues associated with these procedures, is expected as less invasive techniques and technologies to treat heart valve and other related diseases, like congestive heart failure (CHF, which has now reached epidemic proportions in the U.S.), are developed. Details of the agreements were not disclosed.

About PVT:

Percutaneous Valve Technologies, Inc. (PVT) located in Fort Lee, N.J., with a subsidiary in Israel, is a privately held medical technology company developing an innovative, percutaneous approach for delivering heart valves to treat late-stage aortic stenosis (AS).

This less invasive device, designed by PVT, is a proprietary blend of balloon-expandable stent technology with a bioprosthetic valve made from biological tissue.

----?The procedure deploys the stent across the old valve, holding it permanently open allowing for replacement of the old stenotic valve with a new one, thus removal of the failing valve is not required. Cool!

It is designed to be delivered in a cardiac catheterization laboratory (CCL) under local anesthesia, using fluoroscopic guidance, thereby avoiding general anesthesia and highly invasive open-heart surgery techniques currently used in valve replacement.

About 3F:

3F Therapeutics, Inc. (3F) located in Lake Forest, California, and Brussels, Belgium is a privately held company formed in 1998 to develop, manufacture and market innovative devices for the cardiac surgeon.

Presently, the company has its patented 3F Aortic Bioprosthesis in regulated clinical trials in eleven (11) centers in Europe, and has recently received approval by the applicable Federal Agency to start clinical studies in eight (8) centers in the United States.

3F patented technologies, based on a tubular valve concept, lend themselves to minimally invasive surgery (MIS) and will be applicable to both aortic and mitral valve replacement.

3F's focus on the cardiac surgeon is based on the belief that the vast majority of heart valve replacement procedures will continue to be performed by the cardiac surgeon in the operating room.
 
Thanks Rob for keeping us up to date on the research being done. I try to keep up with that board as often as I can, too since I've also had CABG... Cardiostar is a busy researcher and always posts the latest technologies. We're so lucky he can afford the time needed to do this!!! I appreciate your taking the time to foward it here!!!!

Zipper *~*
 
Nice idea on the PVT, but what's the life span on the new bioleaflet valve?
 
Hey Stevo-

Never mind lurking about wasting time--get back in your lab and design some excellent equipment for all these heart guys! We need people like you to do some real improvements on what everyone has!:D :D :D

Just a little "ribbing". It's great to have some inside professionals as members. Welcome to the site.
 
Hey Nancy,

Thanks for the welcome. Not too sure that I'd call myself a professional though!!! :D
 

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