Medtronic suspends recruitment for stent graft study for aortic aneurysm repair

Endurant stent graft system--Courtesy of Medtronic

Back in April 2015, Medtronic ($MDT) launched a clinical study of its Endurant Evo AAA stent graft system. Now, the company is suspending recruitment on the trial after encountering a setback.

The Minnesota device giant had only one patient left to enroll but decided to stop the study so it could look into unanticipated stent fractures, The Gray Sheet reports. The study was designed to look at how well the device could treat abdominal aortic aneurysms, according to a recent filing at ClinicalTrials.gov.

In April 2015, Medtronic kicked off a clinical study to evaluate the system's safety and effectiveness with plans to enroll 140 patients at 30 sites in the U.S. and Europe. Endurant Evo AAA offers an alternative to open surgical repair for patients with abdominal aortic aneurysms.

Researchers said that they would use the number of patients experiencing a major adverse event 30 days after implantation as the study's primary safety endpoint. Scientists also wanted to look at how well the device worked one year postimplantation.

"Medtronic is committed to improving the detection and treatment of aortic disease globally," VP and GM of Aortic Daveen Chopra said in a statement. "The Endurant Evo AAA stent graft system provides another proof point for our enduring commitment to invest in innovation for the endovascular treatment of complex aortic disease."

The halted trial is bad news for Medtronic, which has been working hard to expand in abdominal aortic aneurysm repair. Last year, the company shelled out $110 million for Aptus Endosystems to get its hands on Aptus' aortic aneurysm repair technology. The deal came a day after Medtronic bought the rights to another aortic aneurysm company, Arsenal AAA.

Medtronic faces some stiff competition in the field. Even though the company has said its Endurant system holds about 50% of the global market, other companies such as Endologix ($ELGX) and Lombard Medical ($EVAR) are also making headway with related devices.

Endologix and TriVascular Technologies recently finalized their $211 million merger to create an aortic aneurysm repair powerhouse. Lombard is also staying busy on the deal front with a $50.5 million deal for Altura Medical.

- here's the ClinicalTrials.gov filing
- read the Gray Sheet story (sub. req.)

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