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This article was originally published in The Gray Sheet

Executive Summary

Medtronic's Model 7217B PCD (pacer-cardioverter-defibrillator) is approved for use in patients at risk for sudden death because they have had at least one episode of cardiac arrest resulting from ventricular tachyarrhythmia or they have been diagnosed with recurrent or sustained ventricular tachyarrhythmias, according to FDA approved labeling. The PCD was approved by the FDA on Feb. 11 after approximately two years in review. An FDA advisory panel recommended approval of the device on Feb. 3, 1992 ("The Gray Sheet" Feb. 10, p. 2). The PCD approval brings the first third-generation implantable defibrillator to the U.S. market and is likely to rocket Medtronic to the top of the implantable tachyarrhythmia management device field. Prior to Feb. 11, Lilly's Cardiac Pacemakers division had the only approved implantable defibrillator products -- the second- generation Ventak P, which offers cardioversion and defibrillation, and the first-generation Ventak, which only defibrillates. In background information on the PCD, Medtronic describes the PCD as "the first implantable device to offer a range of automatically administered therapies" to control ventricular tachycardia or ventricular fibrillation. The main portion of the device is a pulse generator that is implanted in the abdomen. The pulse generator is connected to the heart by two sensor leads and two-to-three patch leads that send electrical pulses to the heart. When the PCD senses tachyarrhythmia, it first applies electrical pulses like those of a normal pacemaker. If pacing fails, the generator automatically switches to stronger pulses until the heart's rhythm is corrected. According to a Medtronic press release, "the PCD demonstrated its safety and effectiveness during extensive clinical trials. After one year PCD wearers experienced nearly 99% survival from sudden cardiac death." Referring to trials of the device, Gusty Brady, MD, University of Washington Medical Center in Seattle, said in the Medtronic press release that "approximately 90% of ventricular tachycardia episodes were successfully terminated by pacing," the lowest level of pulses given by the device. "Thus the PCD may extend the lives of individuals at risk for sudden cardiac death without the constant fear of the painful shocks that accompanied use of previously available devices," according to Brady. A disclosure statement included in the device's labeling notes that the Model 7217B is "contraindicated for patients with transient ventricular tachyarrhythmias due to reversible causes" and "patients with transient ventricular tachyarrhythmias due to other factors, e.g., myocardial infarction and electrocution." The device also is not indicated for the "treatment of atrial arrhythmias," the notice says. Among several warnings and potential complications listed in the disclosure statement is that "underlying cardiovascular disease may alter the heart's electrophysiological characteristics and the efficacy of the programmed parameters" of the PCD device. The statement also warns that all pacemakers already in place must be explanted. Electromagnetic interference, the warning states, could cause the device to falsely detect abnormal activity and deliver pulses. Also, supraventricular arrhythmias could be detected by the device as ventricular tachycardia. Complications that result from use of the device may include "failure to detect and/or terminate ventricular tachycardia or ventricular fibrillation, acceleration of a ventricular tachycardia, and lead system related complications." Shipments of the PCD began immediately after the company received the FDA approval letter. Marketing of the product is being conducted by Medtronic's 300-person U.S. sales force. The company says its product will be available first in approximately 100 centers where FDA-mandated training seminars in the implantation and programming of the device have been completed. Medtronic expects to double the number of centers qualified by training to implant the PCD by next year. The firm is introducing the PCD at a list price to institutions of approximately $17,000; the price of the epicardial leads will be approximately $2,000, the company says. The potential patient population for the device "includes 30,000-60,000 survivors of sudden cardiac arrest...and 50,000- 150,000 annually diagnosed with recurrent ventricular tachycardia," the firm estimated in the background press material. Medtronic adds that "some of these persons can be treated with medications, some with ablative techniques. The PCD provides a third alternative." Medtronic began marketing the PCD in Europe in March, 1991 and has since expanded to markets in Canada, Australia and Latin America. The firm estimates that the PCD has been implanted in over 4,000 patients and expects that the device's worldwide market will exceed $1 bil. by the year 2000. Currently, the device is marketed with epicardial leads, which require an open chest thoracotomy procedure for implantation. However, Medtronic is seeking FDA approval for Transvene, a transvenous lead system that would eliminate the need for such surgery. A premarket approval application was filed with the agency in April. The firm also is initiating European clinical trials of two new PCDs in 1993, a lighter weight device and a version with enhanced capabilities ("The Gray Sheet" Jan. 11, p. 30). Slightly behind Medtronic in the approval process is Ventritex, which received an approvable letter for its Cadence V- 100 pacer-cardioverter-defibrillator in December ("The Gray Sheet" Jan. 4, In Brief). Ventritex President and CEO Frank Fischer announced at the Piper Jaffray Cardiovascular conference in New York on Feb. 4 that Ventritex expects approval for the device within three months. The firm also plans to file an investigational device exemption for U.S. clinical trials of its transvenous lead system and is conducting a European study of Cadence V-100C, a device compatible with transvenous leads marketed by Eli Lilly subsidiary Cardiac Pacemakers, Inc. in Europe ("The Gray Sheet" Dec. 7, I&W-8).

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