Thoratec gets FDA approval for increased enrollment and Medicare expansion for heart pump

Thoratec Corporation, a manufacturer of products to treat cardiovascular disease, has announced the expansion of its Phase I feasibility trial for the HeartMate(R) II left ventricular assist system (LVAS).

The HeartMate II is a next generation heart assist device designed to provide long-term cardiac support for patients with end-stage heart failure. The trial, which originally allowed enrollment of up to seven patients in four institutions, will now enlist up to 15 patients at up to 10 centers in the United States.

The FDA approval was granted just 20 days after Thoratec submitted the investigational device exemption (IDE) request for trial expansion. The pilot trial, designed to test the safety and potential effectiveness of the HeartMate II LVAS, began in November 2003, when the first patient was implanted.

A total of four patients have been implanted with the device, with two of these occurring within the past few weeks at the University of Pittsburgh Medical Center and Columbia University Medical Center. One of these patients has been successfully transplanted and the other patients are doing well, with the first two having been supported by the device for nearly six months and four months, respectively.

The news of the trial expansion came on the heels of another FDA action last week that approved HeartMate II patients in the clinical trial to be discharged to a home setting from the hospital, based on the positive outcomes of the trial to date. The first patient cleared for home discharge was at Texas Heart Institute on Monday, April 26.

The company said that at least four of the additional six centers to be added to the trial have already been identified, received all necessary internal approvals, and have been trained on the technology, allowing them to begin screening and treating patients immediately.

"While we are still in the early stages of this trial, we are very encouraged by the overall results to date, as well as the feedback we've received from both clinicians and patients," said D. Keith Grossman, president and chief executive officer of Thoratec. "We are encouraged by the FDA's decision to further expand the trial to allow greater enrollment options and, as a next step, hope that we will be on-track to begin the Phase II pivotal trial by year's end."

Thoratec Corporation has also commented on the proposed rule for the inpatient prospective payment system for Destination Therapy for fiscal year 2005 issued today by the Centers for Medicare & Medicaid Services (CMS).

Under the proposal, all VADs (ventricular assist devices) implanted for Destination Therapy would be reimbursed under DRG (diagnosis-related group) 103, which currently covers heart transplantation procedures, significantly increasing the rate of reimbursement for Destination Therapy procedures.

Currently, Destination Therapy is reimbursed under DRG 525, which covers the implantation of heart assist devices. "The current median reimbursement to those 68 centers recognized by CMS for Destination Therapy reimbursement is approximately $96,000. Based on our preliminary analysis of this CMS proposal, we believe the median reimbursement would increase by around 30 percent to approximately $125,000, with certain centers qualifying for levels significantly higher," said D. Keith Grossman, president and chief executive officer of Thoratec.

The company noted that this is a proposed ruling, and is subject to a 60-day public comment period.

The final rule is due August 1 and would be effective for the fiscal year beginning October 1, 2004. "While any Medicare reimbursement changes will not be effective until later in the year, this is a very positive development for patients suffering from end-stage heart failure and the clinicians who treat them," Grossman added. "As we have indicated in the past, we expect that the majority of Destination Therapy patients will be Medicare beneficiaries. We believe that this proposed payment change reflects CMS' efforts to ensure that patients have adequate access to this lifesaving treatment.

CMS noted that the new Destination Therapy indication is more aligned with heart transplant clinically, as well as in the resources required to treat the patient," he noted. Thoratec's HeartMate(R) XVE LVAS (left ventricular assist system) is the only device approved by the FDA for Destination Therapy, or the permanent support of end-stage heart failure patients who are not eligible for heart transplantation. It is estimated that 100,000 or more patients each year in the U.S. fall into this category.

The company received this approval from the FDA in November 2002. CMS issued a National Coverage Decision for the procedure last October.

For more information, visit the company's web sites at http://www.thoratec.com or http://www.hearthope.com.

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