Medtronic gains FDA approval for stent delivery system for TAA
repair
9 Nov 2010
Medtronic, Inc. has received US FDA approval for its Talent
Thoracic Stent Graft with Captivia Delivery System, which features a tip
capture mechanism for controlled deployment and precise placement of the
implantable medical device.
The Talent Captivia System is used in the endovascular repair of
thoracic aortic aneurysms (TAA), dangerous bulges in the body’s main
artery (near the heart) that can rupture with fatal consequences if
left untreated. While an estimated 60,000 people in the United
States have a TAA, only about half are ever diagnosed due to lack of
symptoms.
During thoracic endovascular aortic repair (TEVAR), the Talent
Captivia System is inserted into the femoral artery in the patient’s
groin and moved up through blood vessels to the aorta. With the
device at the site of the aneurysm, the physician expands the stent
graft within the aorta, creating a new path for blood flow that
reduces pressure on the bulge and the risk of rupture.
“The Captivia Delivery System’s tip capture mechanism is designed
to provide excellent control of the stent graft during deployment to
ensure that blood flow isn’t occluded into the nearby arteries,”
said Dr Edward Y Woo, MD, vice-chief and program director of
vascular surgery and endovascular therapy for the University of
Pennsylvania Hospital System. “This improvement to the delivery
system also increases my confidence in the device’s deployment
accuracy.”
Medtronic now offers the Talent Thoracic Stent Graft in longer
lengths (up to 215 mm in total length) to accommodate the aortic
anatomies of more patients. In addition to tip capture, the Captivia
Delivery System features a hydrophilic coating to ease insertion
into the femoral artery and navigation through the iliac arteries
(around the pelvis) en route to the aorta.
“In partnership with physicians around the world, Medtronic stent
grafts have been used to treat more than 180,000 patients with
aortic disease or injury – more than all other manufacturers
combined,” said Tony Semedo, vice president and general manager of
Medtronic’s Endovascular Innovations business. “FDA approval of the
Talent Captivia System builds on this legacy of leadership in the
field of endovascular aortic repair.”
The Talent Captivia System is indicated specifically for the
endovascular repair of fusiform aneurysms and saccular
aneurysms/penetrating ulcers of the descending thoracic aorta in
patients having appropriate anatomy.