Heart Defibrillator Maker Ventritex To Cooperate With FDA
SUNNYVALE, Calif. (AP) _ Ventritex Inc. conceded Thursday that its sales agents may have been ″overzealous″ in promoting the company’s heart defibrillator and pledged to cooperate with the FDA, which has warned the company to halt the promotions.
The Food and Drug Administration, which regulates medical devices, on Wednesday warned the company not to use ″unsubstantiated and misleading″ statements in promoting the use its Cadence defibrillator in combination with electrical leads produced by Eli Lilly & Co.
The Cadence device has been approved for use by the FDA, but not in conjunction with the Eli Lilly product, called Endotak.
″The safety and effectiveness of this combination has never been established,″ the FDA said in a letter.
The warning requires Ventritex to inform physicians and hospitals using its product that clinical trials have not been conducted, and the agency’s Office of Compliance said it wanted to approve wording of the letters before they go out, said Frank Fischer, Ventritex president and chief executive.
″We intend to fully cooperate to get this done as soon as possible,″ he said.
Ventritex had sales of about $18 million during its most recent quarter. Its larger competitors in the defibrillator market include Medtronic Inc. and Lilly’s Cardiac Pacemakers Inc. unit.
Separately, Fischer responded to recent reports that officers of the company had sold large quantities of stock in recent weeks.
He said several officers, including himself, had recently sold stock but said the sales ″have nothing to do with″ Ventritex’s problems with the FDA.
On Wednesday, Ventritex stock fell $5.75 per share to close on the Nasdaq at $36.50, a 14 percent decline. On Thursday the stock was unchanged.
Fischer said he recently sold 110,000 shares and exercised options and sold an additional 65,000 shares to fund the purchase of a home. The sales constituted about 40 percent of his total stock and stock-option holdings, he said.
According to the stock monitoring service Invest/Net in Fort Lauderdale, Fla., Robert Momsen, a Ventritex director, sold 10,000 shares on Oct. 27, and Benjamin D. Pless, a division officer of the company, sold 32,000 shares.
Fischer said most other officers who recently sold stock had intended to do so last August, but because of a public stock offering scheduled that month they were precluded from doing so by federal securities regulations.