This is a brief overview of information related to FDA's approval to market this product. See the links below to the Summary of Safety and Effectiveness and product labeling for more complete information on this product, its indications for use, and the basis for FDA's approval.
Product Name: Ovatio CRT-D Model 6750, Situs OTW Left Ventricular Over-the-Wire Lead Model UW28D, Situs OTW Stylet kit and Elaview 1.34 UG2 programming software
PMA Applicant: ELA Medical, Inc.
Address: 2950 Xenium Lane North, Suite 120, Plymouth, MN 5541
Approval Date: May 15, 2008
Approval Letter: http://www.accessdata.fda.gov/cdrh_docs/pdf6/p060027a.pdf
What is it?The Ovatio CRT-D System is used to help treat congestive heart failure, a condition where the heart can not adequately pump blood around the body. It does this by providing specially timed electrical impulses to simultaneously stimulate the heart's lower chambers (right and left ventricles). The system consists of a pulse generator (containing a battery and electronic circuitry) connected to three leads (insulated wires) that deliver electrical impulses to stimulate the heart. One lead is placed in an upper heart chamber (right atrium) and the two other leads are placed in each of the ventricles. The system is also capable of delivering high voltage defibrillation therapy when needed to treat life-threatening arrhythmias.
How does it work? The Ovatio System works by the placement of the lead system and then the appropriate setting of the pacing and defibrillation system. In some heart-failure patients, the right and left sides of the heart may not contract together. The Ovatio system sends electrical impulses to the heart to promote simultaneous contraction of both ventricles. The defibrillation system is designed to provide automatic treatment of life threatening arrhythmias.
When is it used? The Ovatio System is used in patients for whom defibrillation therapy is desirable and in patients with NYHA Class III or IV.
What will it accomplish? The Ovatio CRT-D System may relieve some of the symptoms associated with heart failure that include shortness of breath or fatigue during exertion.
When should it not be used? It should not be used in patients who are not candidates for an implanted defibrillator, patients who already have an implanted pacemaker, or in patients for whom the condition is reversible.
Additional information: The Summary of Safety and Effectiveness and labeling will be available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cftopic/pma/pma.cfm?num=p060027