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why are its competitors not important?

  1. Sabretoothed

    34,500 Posts.


    What puzzles me it why its competitors are not important.

    There seem to be many products on the market already which have FDA approval, leading back in the 1990s.

    A short search on google produces many results. http://www.google.com.au/search?q=left+ventricular+assist&ie=UTF-8&oe=UTF-8&hl=en&meta=

    Can VCR holders explain to me the difference of VCR's device and the ones already appproved with FDA in the US?

    Does VCR have a monopoly, since the valuations are very high...

    Personally, I hope it stays up VCR since it seems a lot of people have a lot of interest in this stock, and wish holders all good luck, but I just am interested in people's opinions regarding the USA competitors..


    "These devices are becoming very common and are now available in most heart transplant centers."


    "The device used in the REMATCH study, the HeartMate SNAP-VE LVAS, manufactured by Thoratec, is the only LVAD to date to win FDA approval. "This is truly an extraordinary day for congestive heart failure patients and their doctors," says D. Keith Grossman, president and CEO of Thoratec. "This marks the first time any mechanical heart pump has been approved to provide permanent support for heart failure patients. Given that many patients do not qualify for transplantation and that there is a very limited supply of donor hearts, we are hopeful that this will be an increasingly adopted treatment for patients who have no other options."

    REMATCH Findings Lead to a Historic Decision

    The REMATCH clinical trial compared patients supported by the HeartMate VE to those treated with today's best medical management. The results were published in the New England Journal of Medicine in November 2001 and were ranked by the American Heart Association as the second biggest cardiac breakthrough in 2001.

    A total of 22 premier medical centers throughout the United States participated in the REMATCH trial and now offer Destination Therapy programs. The study enrolled 129 patients who because of their age or other diseases were not eligible for a heart transplant. VADs are not yet covered by Medicare, although it is expected that the Medicare Coverage Advisory Committee will issue a coverage decision soon, and reimbursement guidelines are expected to be in place by the second half of 2003.

    Key findings of the REMATCH study included:

    One-year survival rates nearly doubled and there was an absolute reduction in the mortality rate of 24 percent at one year for patients on VAD therapy, as opposed to those on medications only. At two years, survival nearly tripled and the median survival for VAD patients was 408 days versus 150 days for those in the control group.
    Quality of life, as measured by mobility, functionality, and mental health, was equal to or superior to those being treated medically.
    The level of adverse events (heart attacks, etc.) was acceptable when compared to the natural course of a terminal illness.

    "The severity of illness in the REMATCH trial far exceeded that of patients in all previous heart failure trials," Dr. Rose says. "The mortality of patients in the control group (the group receiving state-of-the-art medications only) was four times that observed in beta blocker trials, and outcomes were worse than patients with AIDS, breast cancer, colon cancer, and lung cancer. Heart failure is a mortal illness. We estimate that treatment with the ventricular assist device will avert 270 deaths per 1,000 patients every year."

    (Revised August 1, 1996)
    "What is the status of permanent ventricular assist pumps?

    Both the HeartMate electrical system and the Novacor unit were ultimately designed to be used as permanent ventricular assist devices. The opportunity to use these as bridge devices has provided the designers and the surgeons with an opportunity to gain experience with these pumps but without the concerns regarding long-term reliability (>one year). The electrical devices are designed to be implanted in the left upper quadrant, fill from the left ventricle, and eject into the aorta. Both of these systems require vent tubes and electric wires that exit from the lower abdominal skin. Ultimately, energy transfer by inductive coupling techniques can be employed with these devices. Some type of implantable compliance chamber would also be required to eliminate the need for any tube or wire to cross the skin.

    Initial clinical use of these devices is just beginning to occur at the present time. With these systems, the patients carry rechargeable battery packs that can be changed at prespecified intervals.

    The extreme shortage of donor hearts and the increasing population of patients with ventricular failure suggests that these devices will play a major role in the treatment of patients with end stage heart disease in the future. At the present time, approximately heart transplants are performed annually. Estimates suggest that as many as 10,000 patients may be candidates annually for cardiac replacement therapy (heart transplantation, permanent left ventricular assist pumps, and the artificial heart).

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