Medtronic (Minneapolis) has launched its Talent Abdominal Stent Graft with a new delivery mechanism called Xcelerant Hydro Delivery System, which is intended to simplify endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAA).
This type of aneurism, an abnormal bulge in the wall of the aorta, can develop over many years and their rupture is fatal in the large majority of cases. In recent years, treatment has been equally split between open surgery and a less invasive procedure. Last spring, the FDA approved Medtronic's Talent on another delivery system (Medical Device Daily, April 17, 2008).
The announcement was made during the 35th annual VEITHsymposium at the New York Hilton, where Medtronic was showcasing its recently-expanded portfolio and pipeline of stent grafts and delivery systems, including the Talent abdominal and thoracic stent grafts and Xcelerant and Xcelerant Hydro delivery systems.
The company said the new delivery system makes the job much easier for surgeons.
"It expands the population that can be treated, with more accurate deployment," Tony Semedo, vice president and general manager of Endovascular Innovations at Medtronic, told Medical Device Daily.
The Xcelerant Hydro Delivery System includes a hydrophilic coating that attracts and holds water at the device surface to reduce friction. The coating is designed to aid navigation through the femoral and iliac arteries en route to the aorta.
The hydrophilic coating gives endovascular interventionalists greater control over the deployment of the stent graft.
"The Xcelerant will replace the CoilTrac Delivery System," Semedo said. "We are converting all of our products over to Hydro Delivery System. It allows for more control and more accuracy. It allows you to unscrew and deploy the graft slowly, giving the physician more control during the procedure."
The product is intended for use in all thoracic and abdominal aneurisms, which expands the population of patients that can be treated.
EVAR involves the navigation of a stent graft, via the body's arteries, to the aorta. The graft is deployed to create a reinforced tube within the aorta, reducing pressure on the aneurysm and the risk of rupture. EVAR is considered to be a minimally invasive alternative to open surgical repair.
"We project that our current share of this market is 39% in the U.S. and 37% worldwide today," Semedo said. "My guess is that this product would expand the patient population [for which the Xcelerant is used] 10% to 15%. It gives us the ability to treat patients who have difficult and challenging anatomies."
Worldwide, it is estimated that more than 1 million people are living with undiagnosed aortic aneurysms, and that 95% of those people could be successfully treated if detected before rupture. About 60,000 AAA surgeries are performed each year in the U.S., split equally between EVAR and open surgery, the latter requiring a large abdominal incision.
The Talent system consists of a woven polyester membrane supported by a tubular metal lattice. It's available in diameters of up to 36 mm, as well as flared and tapered iliac limbs of 8 mm to 24 mm. It has 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.
In 2006, Medtronic paid Edwards Lifesciences (Irvine, California) and Endogad Research (Sydney, Australia) $37.5 million in a patent infringement settlement related to modular or multi-part endovascular grafts especially suited for treatment of various types of aneurysms, including AAA. In exchange, Medtronic was granted non-exclusive licenses to the patents involved in the litigation, as well as to other patents relating to endovascular AAA grafts and delivery systems (MDD, Jan. 24, 2006).
Medtronic reported the European market launch of the Talent Abdominal Stent Graft earlier this year (MDD, March 14, 2008).
A luncheon symposia on recent advancements in EVAR abdominal treatment was held Thursday at the VEITH conference, featuring Piergiorgio Cao, MD, of the University of Perugia in Italy, and Dr. William Jordan, of the University of Alabama at Birmingham.