Register for FDA approves VITALITY2 implantable defibrillator
Guidant Corp.May 3, 2004
Guidant Corp. (GDT) announced it has received market approval from the U.S. Food and Drug Administration (FDA) for its VITALITY2 implantable cardioverter defibrillator system designed to treat patients at risk for sudden cardiac death due to arrhythmia (irregular heartbeat).
The VITALITY 2 implantable defibrillator system is a next-generation device based upon the established VITALITY line of products, and offers distinct advantages for both patients and physicians. The size and physiologic shape of the VITALITY 2, according to the company the world's smallest and thinnest implantable defibrillator at 30 cc and 11 mm, is designed to facilitate ease of insertion and contribute to patient comfort.
"Guidant is committed to treatment options that enable physicians to provide optimal therapy for their patients at risk for sudden cardiac death," said Fred McCoy, president, cardiac rhythm management, Guidant Corp. "The launch of the VITALITY 2 represents an important step forward in our ongoing efforts to help these people live longer."
The VITALITY 2 system also incorporates Guidant's proprietary RHYTHM ID feature, which utilizes rhythm discrimination technology to help manage complex arrhythmias for people at risk of sudden cardiac death. This feature is designed to distinguish lethal from nonlethal heart rhythms and deliver the appropriate care at the appropriate time.
"The combination of size, longevity, and advanced rhythm management options provide great benefits in terms of patient comfort and delivery of appropriate care," said Antonio Curnis, MD, consultant cardiologist, Spedali Civili, Italy. "In particular, the ability of the VITALITY 2 to distinguish between lethal and nonlethal arrhythmia provides enhanced peace of mind to both the patient and physician."
Full market launch of the VITALITY 2 implantable defibrillator is scheduled for May 2004. This article was prepared by Biotech Week editors from staff and other reports.
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