My husband works for Thoratec. The truth is there is a device correction not a recall. It's obvious that someone stands to gain by leaking misleading and incorrect information to the public. Please listen to the conference call tomorrow morning to get the accurate story. There is a conference call scheduled for 8:30 am PDT.
This is from Thoratec's website:
Thoratec Corporation Issues Worldwide Medical Device Correction of HeartMate II(R) Left Ventricular Assist System
PLEASANTON, Calif., Oct. 24 /PRNewswire-FirstCall/ -- Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.
Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.
Thoratec is voluntarily issuing an Urgent Medical Device Correction notice after confirming 27 reports where wear and fatigue to the percutaneous lead necessitated pump replacement. These reports occurred over five years of clinical experience with 1,972 implants. All patients who have undergone a replacement of the HeartMate II pump survived the operation and were alive at least 30 days postoperatively. In five cases, pump replacement was not feasible and the patients expired.
The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.
Full article -
http://phx.corporate-ir.net/phoenix.zhtml?c=95989&p=irol-newsArticle&ID=1217183&highlight=Another article. Source:Bloomberg.com
Thoratec Says Five Patients Died While Using Heart (Update2)
By Andrew Pollack
Oct. 24 (Bloomberg) -- Thoratec Corp. said five people died while using its mechanical heart that is smaller than a D-cell battery and urged doctors and patients to check the devices for damage.
Thoratec's shares plunged 52 percent to $12 in extended trading on the Nasdaq Stock Market at 5:21 p.m. New York time after the announcement.
Thoratec said it received 27 reports over five years of wear and fatigue to an electrical wire connected to its HeartMate II device, which caused the pump to fail. In five cases, replacement of the heart pump ``was not feasible'' and the patients died, the Pleasanton, California-based company said in a statement on PR Newswire.
Thoratec said 1,972 devices have been implanted in the five years since clinical trials began on HeartMate II. The mechanical heart, approved by U.S. regulators in April, circulates the blood to help patients survive until a transplant organ becomes available. The pump, which fits children, women and small men, was expected to help Thoratec in a $3 billion U.S. market for patients awaiting life-saving transplants.
There is a 1.3 percent probability the wire fatigue will result in the need for a pump replacement at 12 months, the company said in its statement. The probability of a replacement rises to 6.5 percent at 24 months and 11.4 percent at 36 months, Thoratec said.
http://www.bloomberg.com/apps/news?pid=newsarchive&sid=avDTTrtCRGGA