Fueling its drive for U.S. market leadership in coronary stents, Medtronic, Inc. (NYSE: MDT) today announced that it has received approval from the U.S. Food and Drug Administration to commercialize its S7 With Discrete TechnologyÔ Coronary Stent Systems. The S7 coronary stent succeeds the popular S670 coronary stent and is now available for immediate shipment to interventional cardiologists in and outside of the United States.
The S7 coronary stent is the latest in a succession of Medtronic AVE stent systems for use in a therapy known as percutaneous transluminal coronary angioplasty (PTCA). Available in both over-the-wire and rapid exchange versions, the seventh generation S7 coronary stent system combines the preferred attributes of the S670 – its deliverability and ease-of-use - with additional design enhancements that provide an optimal balance of trackability, deliverability and scaffolding. The S7 coronary stent on the rapid exchange delivery catheter offers perfusion capabilities at an average rate of 2cc/minute at nominal pressure.
“Interventional cardiologists want the best of both worlds when it comes to treating lesions within the coronary anatomy, and Medtronic AVE has delivered with the S7,” said Andy Rasdal, president of Medtronic Vascular. “With its excellent deliverability and increased scaffolding, the S7 is poised to become the stent of choice for physicians worldwide.”
Jeffrey Popma, M.D., Director of Interventional Cardiology at Brigham and Women’s Hospital in Boston, Mass. and Associate Professor of Medicine at Harvard Medical School added that “Medtronic AVE’s modular stent technology has continuously evolved over the years to meet the demands of daily clinical practice, and the latest result is the S7 stent, an extremely flexible and deliverable stent that provides improved scaffolding and surface coverage. We are excited about the clinical and angiographic results we have seen with the S7 stent thus far.”
With the U.S. introduction of the S7 coronary stent, Medtronic AVE becomes the only company in the industry to introduce seven generations of modular stent technology worldwide in six years. Features for the S7 include:
Ø New Modular Stent Design. The S7 consists of shorter element lengths (1 millimeter) with a smaller cross-sectional area and a new ten-crown design, outnumbering the crowns now available on any U.S.-approved stent. These new design characteristics provide physicians with the additional flexibility they need for tracking through tortuous anatomy and reaching difficult to access lesions. The smaller cells (which each measure less than 1 millimeter squared) allow the S7 stent to offer improved scaffolding and better coverage of the lesion, even on bends.
Ø New Balloon Material. The S7 delivery system features a new balloon designed specifically for the S7 stent. The new balloon material is softer, which improves the system’s flexibility, trackability and deliverability. This material also provides physicians with greater control at higher pressures during inflation and deployment.
Ø Proven Delivery Technologies. The S7 stent platform incorporates two proven Medtronic AVE delivery technologies – Discrete TechnologyÔ and Secure TechnologyÔ.
-Discrete Technology provides for precise alignment of the stent on the balloon, thereby minimizing the balloon overhang extending beyond the ends of the stent and minimizing the possibility of dilating healthy tissue.
-Secure Technology is a patented system designed to ensure that the stent remains securely on the balloon during delivery, positioning and deployment. Proximal and distal balloon pillows, as well as pillows around and between the stent’s struts, are created by a combination of heat and pressure to provide added security for tracking through tortuous anatomy.
Ø Optimal Radiopacity. The S7 stent has optimal radiopacity, in that its appearance under fluoroscopy enables the physician to precisely place the stent and to more clearly view the clinical result within the coronary anatomy.
The S7 coronary stent is available in diameters of 3.0, 3.5 and 4.0 millimeters and in lengths of 9, 12, 15, 18, 24 and 30 millimeters.
Additionally, Medtronic AVE has opened the DISTANCE trial (Direct Stenting with Angiographic and Clinical Evaluation of the S7) in markets outside of the United States. This study is evaluating the use of the S7 in direct stenting procedures. The S7 is not approved for direct stenting in the United States.
The S7 With Discrete Technology Coronary Stent Systems join the BeStentÔ2 and S660Ô coronary stent systems as well as the D1 and R1 balloon catheters, as components of a complete therapeutic system for treating cardiovascular disease. Other products include guide catheters (ZumaÔ and Z2Ô), steerable guidewires (Fusion), diagnostic catheters and accessories for angioplasty procedures.
Medtronic, Inc., headquartered in Minneapolis, is the world’s leading medical technology company, providing lifelong solutions for people with chronic disease. Its Internet address is www.medtronic.com. Medtronic AVE, formerly Arterial Vascular Engineering, Inc., is headquartered in Santa Rosa, Calif.
