FEATURE/EP MedSystems enters agreements with InControl.BUDD LAKE, N.J.--(BUSINESS WIRE FEATURES)--Aug. 15, 1996--EP MedSystems Inc. (Nasdaq: EPMD EPMD Erick and Parrish Making Dollars (rap group) EPMD Electric Plant Monitoring Device EPMD Enlisted Personnel Management Director/Directorate ) announced today that it has entered into supply and distribution agreements with InControl Inc. InControl is the leader in the development of an implantable device for the treatment of symptomatic atrial fibrillation and is the only company with an implantable atrial defibrillation Defibrillation Definition Defibrillation is a process in which an electronic device sends an electric shock to the heart to stop an extremely rapid, irregular heartbeat, and restore the normal heart rhythm. device under clinical investigation. EPMD is a manufacturer and supplier of a range of cardiac electrophysiology products, including catheters for treating atrial fibrillation. Under the terms of the agreements, EPMD will supply InControl its dual shock temporary atrial defibrillation catheter, which utilizes electrodes on a single catheter positioned in the coronary sinus of the heart. EPMD will have non-exclusive rights to the catheter within the United States. Additionally, EPMD has agreed for InControl to distribute its patented ALERT catheter in certain foreign countries. The ALERT catheter is used as a therapy for providing low energy cardioversion Cardioversion Definition Cardioversion refers to the process of restoring the heart's normal rhythm by applying a controlled electric shock to the exterior of the chest. of atrial fibrillation. EPMD intends to file for an FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. Investigational Device Exemption An Investigational Device Exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data required to support a Premarket Approval (PMA) application or a Premarket Notification [510(k)] submission to Food and to begin clinical trials of the ALERT system in the United States. EPMD has also granted InControl non-exclusive worldwide distribution rights to the ALERT Companion, its external device for delivering energy to the catheter for defibrillation. EPMD's chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. , David Jenkins, stated, "This is a good opportunity for both companies: we are facing a marketplace with over 5 million atrial fibrillation patients in the industrialized in·dus·tri·al·ize v. in·dus·tri·al·ized, in·dus·tri·al·iz·ing, in·dus·tri·al·iz·es v.tr. 1. To develop industry in (a country or society, for example). 2. world and this joint effort of products and resources should allow both companies to take an early leadership position in this evolving market." EP MedSystems develops, markets, sells and services cardiac electrophysiology ("EP") products used to diagnose, monitor and treat certain cardiac disorders. The company's EP product line includes the EP WorkMate(TM) Computerized Electrophysiology Workstation, the EP-3(TM) Computerized Electrophysiology Stimulator and EP catheters. The company has also developed the ALERT Catheter System, which uses a proprietary catheter to deliver low energy electrical impulses directly to the inside of the heart in order to convert atrial fibrillation to a normal heart rhythm. CONTACT: EP MedSystems Inc., Budd Lake James J. Caruso, Chief Financial Officer, 201/691-6400 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion