Medtronic treats first patient with its investigational graft for aortic aneurysm repair

Medtronic's Valiant TAAA stent graft system--Courtesy of Medtronic

Medtronic ($MDT) signaled its interest in abdominal aortic aneurysm repair last year with the $110 million acquisition of Aptus Endosystems and investment in Arsenal AAA in return for an option to acquire the company. The bigwig just announced another piece of AAA news, saying the first patient was treated in its trial of the Valiant TAAA Stent Graft System for thoracoabdominal aortic aneurysm.

The 58-year-old female had few other options for treatment of her aneurysm, Medtronic said. "The mortality rate is 25 percent when treating a thoracoabdominal aortic aneurysm with an open surgical technique, which involves cutting open the aorta," said principal investigator Dr. Patrick Kelly in a statement. "Providing the patient with an option for a less-invasive approach is needed. This procedure marked an important step in the process to obtain FDA approval, and Sanford's support of such innovation will give hope to patients afflicted with challenging disease states such as this."

Kelly helped develop the device in collaboration with Medtronic and performed the procedure at a Sanford Health hospital in Sioux Falls, South Dakota. The operator of 43 hospitals in 9 states, Sanford Health holds the intellectual property covered by the exclusive patent license agreement with Medtronic.

Endovascular stent grafts offer a catheter-based, minimally invasive option to seal a ruptured abdominal aneurysm in the aorta, the main blood vessel that supplies blood to the body. A burst aneurysm can lead to dizziness, vomiting, low blood pressure and life-threatening internal bleeding, among other complications.

Medtronic says thoracoabdominal aneurysms start in the chest and extend throughout the abdomen. They represent about 15% of all thoracic aneurysms and typically affect the arteries that branch off of the aorta.

"The Valiant TAAA approach allows for the procedure to be staged at any time and lets the operator work on each branch vessel individually," said Dr. James Black III, chief of the division of vascular surgery and endovascular therapy at Johns Hopkins Hospital. "When taking on challenging cases, the device leverages skill sets that are quite routine for vascular surgeons."

Medtronic claims that almost half of all endovascular aortic repairs are conducted with one of its devices. At the November VEITHsymposium for vascular specialists in New York City, the company said that the freedom from aneurysm-related mortality rate was above 98% 4 years after use of the Endurant stent graft, citing postmarket registry data.

AAA competitors Endologix ($ELGX) and TriVascular Technologies recently completed their $211 million merger, while Lombard Medical ($EVAR) responded to Medtronic's AAA wheeling and dealing by acquiring Silicon Valley's Altura Medical for up to $50.5 million.

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