Medtronic, Inc. (NYSE: MDT), today announced the worldwide launch of the Sprint Quattro SecureTM (Model 6947) steroid-eluting right ventricular lead used with implantable cardioverter-defibrillators (ICDs) that detect and treat rapid and potentially lethal heart rhythms. The Sprint Quattro Secure, with true bipolar sensing and dual coil defibrillation, is the world’s first quadripolar defibrillation lead to feature screw-in fixation. Screw-in fixation offers flexibility in securing the ICD lead in various right ventricle locations.
As part of its worldwide launch, Medtronic announced it has received U.S. Food and Drug Administration (FDA) approval and the CE (Conformité Européene) Mark for the Sprint Quattro Secure, the latest addition to the company’s industry-leading family of defibrillation leads. The Sprint Quattro Secure ICD lead, designed to provide patient safety and unequaled sensing and defibrillation capabilities, features:
· true bipolar electrodes that pace and sense the heart’s electrical signals while reducing oversensing;
· dual defibrillation coils to efficiently deliver energy to the heart with reduced defibrillation thresholds;
· small lead body (8.6 French) and introducer (9 French) — the Sprint Quattro family of ICD leads has the smallest lead body and introducer of all quadripolar defibrillation leads on the market;
· polyurethane overlay for implantation ease;
· redundant insulation on conductor coil and cables; and
· steroid elution for reduced inflammatory response and pacing thresholds.
“I get everything I want with the Sprint Quattro Secure — superior handling and performance, a dual coil option for lower defibrillation thresholds, true bipolar sensing and active fixation,” said Dr. Steven J. Compton, FACC, Alaska Heart Institute in Anchorage, Alaska, a Sprint Quattro Secure clinical investigator. The Sprint Quattro Secure ICD lead is used with various ICD devices such as the Medtronic GEMÒ family of ICDs and also will be used with the new Medtronic MarquisÒ DR, an ICD that is in clinical trial in Europe and Canada.
The Sprint Quattro Secure 6947 is Medtronic’s second true bipolar sensing and dual coil defibrillation lead. The Sprint Quattro 6944 offers quadripolar lead design with passive fixation and a high-impedance HaloeÔ tip electrode for efficient pacing. “This innovative lead is one of many significant new products scheduled for release in the next year by Medtronic Cardiac Rhythm Management,” said Steve Mahle, president of Cardiac Rhythm Management. “This unprecedented and unmatched product pipeline will extend Medtronic’s leadership in cardiac disease management, enabling us to give patients proven treatment options and provide physicians with the latest technology to effectively manage cardiac patients.” Sudden cardiac arrest, an abrupt loss of heart function that can lead to death in minutes without effective treatment, is a major heath problem. Worldwide, it is estimated that less than 15 percent of patients who are indicated for the life-saving protection offered by ICDs actually receive them. In the United States alone, approximately 220,000 people die each year from sudden cardiac arrest.