Medtronic touts registry data in support of its stent graft for aortic aneurysm repair

Endurant stent graft system--Courtesy of Medtronic

Medtronic ($MDT) touted four-year global registry data that's supportive of its Endurant stent graft system for endovascular abdominal aortic aneurysm repair, which it says has global market share of nearly 50%.

At the VEITHsymposium for vascular specialists in New York City, the company said that the freedom from aneurysm-related mortality rate was 99.2% after 4 years, among the cohort of patients with short AAA neck lengths (above 10 millimeters, but less than 15 millimeters), and 98.3% for those with standard AAA neck lengths (15 millimeters or greater).

In addition, the company said the registry found a "low" rate of aneurysm rupture and conversion to open surgery, as well as no significant difference between the cohorts "in terms of secondary endovascular procedures."

"Analysis of the patient cohort from the four-year global Engage registry included several anatomically challenging sub-groups: short, highly angulated, and calcium/thrombus burdened AAA necks. These mid-term outcomes offer clinical insight into the treatment of AAA neck anatomies relevant and applicable to current clinical practice and real world settings," said Dr. Hence Verhagen, the chief of vascular surgery at Erasmus University Medical Center in Rotterdam, the Netherlands, in a statement. He presented the study results at the symposium.

The Endurant's U.S. indications for use are a little bit more restrictive than those internationally, where treatment of some patients with infra-renal angulation less than or equal to 75 degrees is permitted.

"Through dedication to clinical data and innovation in technology, we hope to expand EVAR (endovascular aneurysm repair) treatments to previously untreatable patient populations," said Daveen Chopra, a vice president and general manager within Medtronic's aortic and peripheral vascular division, in a statement.

Medtronic demonstrated its commitment to the space via two investments made in June, which were followed by additional M&A activity from competitors.

It spent $110 million to acquire Aptus Endosystems, maker of the FDA-cleared Heli-FX, which deploys anchors to lock endografts to the aorta and permanently seal abdominal aortic aneurysms. The device is also used to repair grafts that lose position (or "migrate") or do not form a seal with the vessel wall, resulting in endoleaks.

In addition, the company invested in and gained the option to acquire Arsenal AAA, which is developing a foam and accompanying delivery mechanism to fill the aneurysmal sac around endografts.

Shortly thereafter, competitor Lombard Medical ($EVAR) added a second endovascular stent graft to its portfolio with the acquisition of Silicon Valley's Altura Medical for up to $50.5 million. And Endologix ($ELGX) seeks to merge with TriVascular Technologies in a $211 million transaction designed to create an abdominal aortic aneurysm powerhouse, though Wall Street reacted to the October news by pushing Endologix shares down 25%.

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 life-threatening internal bleeding, dizziness, vomiting and low blood pressure, among other complications.

Medtronic has said 1.5 million Americans have an abdominal aortic aneurysm, with 200,000 new cases diagnosed every year.

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