Ventritex Receives FDA Clearance for its TVL Transvenous Lead System and Pectoral Implantation of Cadet Defibrillators; Cadet/TVL System Improves Patient Comfort, Facilitates Implantation.

SUNNYVALE, Calif.--(BUSINESS WIRE)--May 10, 1996--Ventritex, Inc. (NASDAQ:VNTX) today announced that the U.S. Food and Drug Administration (FDA) has granted the company clearance to begin commercial distribution of the TVL transvenous lead system, and to label and market Cadet implantable cardioverter defibrillators (ICDs) for placement in the pectoral (chest) region of patients with abnormally rapid heartbeats.

Initially cleared by FDA in December 1995 for implantation in the abdomen, the Cadet V-115 and LT V-105 defibrillators are among the smallest and most technologically advanced ICDs commercially available in the United States. At 73 cubic centimeters and 129 grams, the Cadet ICDs are designed to significantly increase patient comfort.

Approved for use with all Ventritex defibrillators, the TVL lead system eliminates the need for open-chest surgery in patients requiring defibrillation therapy. Inserted through a vein, the TVL lead system connects the defibrillator to the heart and is designed to both detect arrhythmias and deliver electrical pulses to the heart to terminate episodes of ventricular tachycardia and ventricular fibrillation.

"We are very happy to be able to market Cadet defibrillators with our own transvenous lead system, which offers superior handling characteristics and flexibility in a wide range of patients," stated Frank Fischer, Ventritex president and chief executive officer. "In addition, our ability to label and promote Cadet ICDs for pectoral implantation should expand the use of both of these products among physicians, who want smaller devices and easier, less-invasive implant procedures."

TVL Lead System

In clinical trials involving more than 300 patients at 35 medical centers, the TVL transvenous lead system provided high success rates, superior pacing and sensing characteristics, and low defibrillation thresholds in a variety of patients. Low pacing and defibrillation thresholds can help to extend battery life and reduce the chance that a patient will require surgical implantation of an extra patch for successful defibrillation.

According to Thomas Mattioni, M.D., director of electrophysiology at the Arizona Heart Institute, "Compared to other available lead systems, TVL leads are more flexible and easier to manipulate. Because they offer the maneuverability of permanent pacemaker leads, physicians are very comfortable with the handling characteristics of the TVL lead systems."

Cadet Features

The downsized Cadet ICDs are designed to increase patient comfort and reduce the trauma associated with the implantation procedure. In addition, they provide eight minutes of electrogram storage, a substantial increase over that offered by other devices. Stored electrograms provide a record of cardiac activity preceding and during an arrhythmic episode, as well as data on the administered ICD therapy. This critical information can be used to improve the diagnosis and management of patient arrhythmias. The Cadet ICDs also offer the highest energy output of any commercially available pectorally implantable device -- a maximum of 38 joules delivered -- resulting in greater safety margins for patients.

The Cadet V-115 is equipped with tiered-therapy capabilities, including antitachyardia pacing (ATP) -- a series of low-level electrical pulses to terminate episodes of ventricular tachycardia -- along with low-energy cardioversion shock and high-energy defibrillation shock. The Cadet LT V-105 offers cardioversion and defibrillation shock without ATP. Both devices produce a biphasic defibrillation shock, which has become the preferred waveform in ICD therapy because of its ability to reduce the amount of energy needed to defibrillate a patient.

Expanding Patient Indications

Patients likely to benefit from implantable defibrillator therapy include the 20,000 to 40,000 people annually in the U.S. who survive an episode of sudden cardiac death (SCD), or the 100,000 Americans annually who are diagnosed with sustained ventricular tachycardia, a very rapid, dangerous heart rhythm.

In addition, results of a recent large clinical trial, the Multicenter Automatic Defibrillator Implantation Trial (MADIT), suggest that an additional 30,000 to 80,000 high-risk, post-heart attack patients annually in the U.S. could benefit from the prophylactic use of ICDs. The MADIT trial was stopped early in March 1996 because those patients who received ICDs experienced 50 to 60 percent fewer deaths compared to patients receiving traditional drug therapy.

Ventritex was founded in 1985 to develop, manufacture and sell implantable defibrillators and related products for the treatment of ventricular tachycardia and ventricular fibrillation, the most serious and life-threatening forms of abnormal heart rhythms. The company has been an innovator in the field of ICD technology since it introduced the Cadence V-100 defibrillator in 1989. The company employs more than 500 people and maintains a 150,000-square-foot facility in Sunnyvale, Calif.

CONTACT: Ventritex

Frank M. Fischer, 408/738-4883

Michael B. Sweeney, 408/738-4883