Healthcare Industry News:  Vascular Stent 

Devices Interventional FDA

 News Release - April 16, 2008

FDA Approves Medtronic's Talent(TM) Abdominal Stent Graft for Repairing Aortic Aneurysms

Innovative Medical Device Enables Minimally-Invasive Treatment of Potentially Fatal Condition

MINNEAPOLIS--(HSMN NewsFeed)--Medtronic, Inc. (NYSE: MDT ), today announced approval from the U.S. Food and Drug Administration for use of the Talent™ Abdominal Stent Graft on the CoilTrac Delivery System, an innovative medical device that expands patient access to a minimally-invasive treatment option for abdominal aortic aneurysms.

Present in an estimated 1.2 million people and responsible for approximately 15,000 annual deaths in the United States, an abdominal aortic aneurysm (AAA) is a dangerous bulge or weakening of the body’s main artery that can rupture with fatal consequences if left untreated. Ruptured AAAs are currently the 10th leading cause of death among U.S. men over age 55, with fewer than 20 percent of people surviving a rupture. But early detection through painless ultrasound screening and minimally invasive treatment with a technique called endovascular repair (EVAR) have historically shown a significant improvement in the survival rate for patients of all ages.

“This important milestone demonstrates Medtronic’s leadership and commitment to the field of aortic repair,” said Katie Szyman, vice president and general manager of the Endovascular Innovations business at Medtronic. “Endovascular interventionalists in the United States now have access to the broadest portfolio of stent grafts for the treatment of their AAA patients. The Talent Abdominal System significantly increases the number of AAA patients who can benefit from minimally-invasive repair. As an alternative to open surgical repair, this device will save the lives of many people affected by abdominal aortic aneurysmal disease.”

Expanding Indication for EVAR

The Talent Abdominal Stent Graft System makes endovascular repair (EVAR) accessible to an additional 20 percent of AAA patients, because of its unique proximal aortic neck length requirement of only 10 mm. Consisting of a woven polyester membrane supported by a tubular metal lattice, the device is specifically indicated for endovascular treatment of abdominal aortic aneurysms with or without iliac involvement. The stent graft is available in diameters of up to 36 mm, as well as flared and tapered iliac limbs of 8 mm to 24 mm.

With a 12-year history of strong clinical performance including more than 45,000 implants worldwide, the Talent Abdominal Stent Graft is designed to offer broad patient applicability, suprarenal fixation and positioning accuracy. The stent graft features radiopaque markers for visual guidance during deployment and follow up, and the delivery system uses a single-step release mechanism for smooth deployment and a coiled rod for enhanced trackability and flexibility.

“The Talent Abdominal Stent Graft has provided excellent patient outcomes in clinical practice and in clinical study,” said Dr. Michael L. Marin, professor of Vascular Surgery and chairman of the Department of Surgery at The Mount Sinai Medical Center in New York. “In my own experience, with more than 750 successful implants using the Talent System, the performance of this stent graft has been very consistent, and its safety and efficacy have been well characterized through the results of our own clinical trial.”

Advantages Over Open Repair

The Medtronic-sponsored clinical study of the Talent Abdominal Stent Graft System enrolled 166 patients at 13 medical centers between February 2002 and April 2003. All 166 patients received a Talent Abdominal Stent Graft; their outcomes were compared to those of 243 patients from the Society of Vascular Surgery (SVS) Surgical Control Group at 30 days and one year post-implant. Dr. Frank Criado, director of Union Memorial Hospital’s Endovascular Program in Baltimore, was the principal investigator for the study.

The study demonstrated that the Talent Abdominal Stent Graft well exceeded the SVS Control in freedom from major adverse events at 30 days, with a statistically significant difference between the two groups: Talent, 89.2%; SVS Control, 44.0%. Although patients receiving the Talent Abdominal Stent Graft were older and had a higher baseline rate of co-morbidities, at 30 days post-implant they experienced lower rates of major adverse events compared with subjects treated with open surgery. Importantly, there were no aneurysm ruptures and no conversions to open surgery in the Talent group up to 12 months after device implantation.

“As Talent is already the leading stent graft for endovascular treatment of AAAs outside the United States, its approval by the FDA is a most welcome and exciting development,” Dr. Criado said. “AAA patients in this country can now enjoy the benefits of this device, which has been shown in the pivotal clinical trial to have distinct advantages over standard surgical treatment.”

In previous studies, EVAR has been shown to be an effective therapy for AAA, with fewer postoperative complications and shorter recovery times than open surgical repair. Results from a U.S. study published recently in The New England Journal of Medicine (Jan. 31, 2008), for example, indicate that perioperative mortality was significantly lower after EVAR than after open repair: 1.2 percent vs. 4.8 percent – a fourfold difference. Similarly, in a landmark study conducted in the United Kingdom and published in The Lancet (Sept. 4, 2004), the 30-day mortality rate for EVAR patients was 1.7 percent compared to 4.7 percent for patients who underwent open repair – a nearly threefold difference.

Although AAAs typically produce no symptoms until rupturing, they can be detected through a simple, painless and inexpensive ultrasound screening, which is offered free-of-charge to new Medicare beneficiaries. If detected before rupturing, AAAs with diameters of more than twice the size of the normal infrarenal aorta are typically treated with either open surgical repair or endovascular repair (EVAR). In contrast to open surgical repair, EVAR involves a minimally invasive procedure in which a stent graft is threaded through the femoral artery in a compressed state on a delivery system and expanded inside the aorta at the site of the aneurysm. Once in place, the stent graft creates a new path for blood flow, reducing pressure on the aneurysm.

As a pioneer of endovascular therapy development, Medtronic has been an innovator and leader in the endoVascular Stent graft industry for more than a decade, as evidenced by more implants than any other company. Its long history includes more than 130,000 patients treated with stent grafts dating back to 1995. Medtronic currently offers the broadest portfolio of endoVascular Stent grafts in the industry. These include the AneuRx AAAdvantage® and Talent Abdominal Stent Graft Systems in the United States, and the Talent Abdominal, Talent Thoracic and Valiant® Thoracic Stent Graft Systems outside the United States.

About Medtronic

Medtronic, Inc. (, headquartered in Minneapolis, is the global leader in medical technology – alleviating pain, restoring health, and extending life for millions of people around the world.

Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic’s Annual Report on Form 10-K for the year ended April 27, 2007. Actual results may differ materially from anticipated results.

Source: Medtronic

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