Medtronic, Inc. announced it received Japanese regulatory approval of the Sprint Quattro™ (Model 6944 and 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 6947, with bipolar sensing and dual coil defibrillation, is Japan’s first 8.6 French defibrillation lead to feature screw-in fixation. Screw-in fixation offers flexibility in securing the ICD lead in various right ventricle locations. The company hopes to receive reimbursement for Sprint Quattro by January 1, 2008, which then would allow for its immediate commercial launch in Japan.

Previously approved and used in Europe and the United States since 2001, the Sprint Quattro 6947 Screw-In ICD lead has a proven performance record and patient safety profile, with established sensing and defibrillation capabilities. The Sprint Quattro 6947 Screw-In ICD lead is used with various ICD and cardiac resynchronization therapy (CRT) devices such as the Medtronic Concerto¨ CRT-D, and the Virtuoso¨ VR ICD, both of which were introduced in Japan in July 2007.

Features of the Sprint Quattro 6947 Screw-In lead include:

• 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);
• polyurethane overlay for implantation ease;
• redundant insulation on conductor coil and cables; and
• steroid elution for reduced inflammatory response and pacing thresholds.

The introduction of the Sprint Quattro leads in Japan adds to the list of significant product and clinical milestones for Medtronic Japan, including:
• recent approval of the company’s therapeutic advances, including the Concerto-AT CRT-D, Virtuoso DR ICD, and Adapta pacemaker;

• involvement in the worldwide clinical trial, Medtronic Concerto™ Cardiac Resynchronization Therapy Defibrillator with Atrial Therapies (CONCERTO-AT), which seeks to assess the safety and efficacy of atrial defibrillation therapy in patients with current indications for CRT-Ds; and
• initiation of the Miracle-ICD Outcome Measured In Japanese Indication (MOMIJI) clinical trial; the first large-scale, post-market study to evaluate the effectiveness of CRT-D therapy in Japanese patients as compared to patients studied in the MIRACLE-ICD trial.