Guidant Says FDA OKs Sale of Heart Failure Implants

Aug 01 - Guidant Corp. said on Monday it received U.S. approval to relaunch its top-selling implantable heart failure devices after a recall and that the products would return to the market by midweek.
Medical device maker Guidant, which is in the process of being acquired by Johnson & Johnson for $25.4 billion, had in June stopped its Contak Renewal 3 and 4 heart failure products from use in implants and halted distribution after they were found to have defects in a switch component.
The approval by the U.S. Food and Drug Administration to reintroduce the Contak Renewal 3 device in the United States means Guidant soon will be back on the market with the vast majority of its product line, analysts said.
Guidant said it expects to have a full supply of the products available this month. The company received European clearance last week to relaunch the Contak Renewal 4 heart failure devices.
The Contak Renewal combination defibrillator and pacemaker devices are the company's most advanced products.
Indianapolis-based Guidant said it expects by midweek to resume worldwide distribution and implants of the devices, which are used to treat patients with heart failure and guard against dangerous heart rhythms.
The recall of the sophisticated combination devices followed a separate recall of several older models of the company's implantable cardioverter defibrillators (ICDs), which were linked to two deaths and 43 reports of malfunctions.

source: reuters


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