Free Newsletter
Register for our Free Newsletters
Analysis, Inspection and Laboratory
Assisted/Independent Living
Clinical and Nursing Equipment
Design and Manufacture of Medical Equipment
Diagnostics Equipment, Monitoring and Test
Education, Training and Professional Services
Health Education and Patient Management
Health Estates Management
Healthcare Support and Information Services
Hygiene and Infection Control
IT and Communications in Healthcare
Medical Device Technology
Research and Development
Safety and Security
View All
Other Carouselweb publications
Carousel Web
Defense File
New Materials
Pro Health Zone
Pro Health Zone
Pro Security Zone
Web Lec
Pro Engineering Zone

Medtronic’s Sprint Quattro defibrillation lead receive Japanese regulatory approval

Medtronic : 17 December, 2007  (New Product)
Medtronic has received Japanese regulatory approval for 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 USA 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.

“We are pleased to have taken this first step to make the Sprint Quattro defibrillation lead available to physicians in Japan,” said Pat Mackin, president and senior vice president for the Cardiac Rhythm Disease Management business at Medtronic. “The Quattro lead has emerged as the gold standard in lead performance. The availability of the Quattro lead in Japan will provide Medtronic the opportunity to continue its market leadership in defibrillators and defibrillation leads in this very important market.”

The introduction of the Sprint Quattro leads in Japan add to the list of significant product and clinical milestones for Medtronic Japan, including:
- recent approval of the company’s leading 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.

Bookmark and Share
Home I Editor's Blog I News by Zone I News by Date I News by Category I Special Reports I Directory I Events I Advertise I Submit Your News I About Us I Guides
   © 2012
Netgains Logo