ZOLL LifeVest
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History of the LifeVest System

The LifeVest was developed by ZOLL Lifecor’s dedicated team of professionals, many of whom were key team members in the development of the world's first implantable defibrillator at Medrad/Intec. Throughout the development process, the LifeVest went through vigorous testing and clinical trials.

Dr. Arthur Feldman, professor and chief, Division of Cardiology, at the University of Pittsburgh Medical Center, was the lead investigator for the US clinical trials. The LifeVest was extensively tested for 3 years in 17 major medical centers across the US and involved 289 patients world-wide. The clinical data collected from those trials allowed LIFECOR to obtain FDA approval for use of the LifeVest in the US. (Read about the clinical trials.)

Professor Helmut Klein, M.D., a leading European cardiologist, implanted the first ICD in Germany and supervised the MADIT II coordinating center activities for Europe. Under the direction of Professor Klein, Magdeburg physicians have tested three generations of the LifeVest system. Through their pioneering work, ZOLL Lifecor obtained the clinical experience leading to European marketing approval.

Key LifeVest Milestones
July 2008 GMP Follow-up Factory Inspection
April 2008 PMA Supplement Approval for V04.1 Software
August 2007 PMA Supplement Approval for WCD 3000 Battery Pack
November 2006 PMA Supplement Approval for WCD 3100 Monitor
May 2006 GMP Follow-up Factory Inspection
March 2006 ISO 13485 (2003 edition)
February 2005 PMA Supplement Approval for V04.0 Software
May 2004 PMA Supplement Approval for the WCD 3000S System
September 2003 PMA Supplement Approval for V02.9 Software
October 2002 Supplement Approval for the WCD 3000 System
July 2002 ISO 13485 (1996 edition) + ISO 9001:1994
June 2002 Product Demonstration for FDA Post-market Surveillance Group
October 2002 FDA Marketing Approval for the LifeVest WCD 3000 System Granted
February 2002 CE Mark Approval for the LifeVest WCD 3000 Electrode Belt
December 2001 FDA Marketing Approval for LifeVest WCD 2000 System Granted
September 2001 CE Mark Approval for the LifeVest WCD 3000 System
April 2001 Pre-market Approval Submission
October 2000 DME Medicare Supplier Approval
April 2000 CE Mark Approval for LifeVest WCD 2000 System
September 1999 ISO 9001 (1994 edition) + EN 46001
August 1999 Release of Second Generation LifeVest device
February 1999 First Successfully Treated Spontaneous SCA Event
November 1998 Commencement of the BIROAD Clinical Trial
September 1998 ISO 9002 (1994 edition) + EN 46002
February 1998 Commencement of the WEARIT Outpatient Clinical Trial
December 1997 Conclusion of In-Hospital Clinical Trial
February 1997 Conclusion of Electrophysiology Lab Trial
June 1996 Investigational Device Exemption (IDE) Approval
May 1996 FDA Classification as a Reimbursable Device

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