Medtronic wins expanded FDA nod for Endurant II stent graft
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Endurant II and IIs stent graft systems designed to treat abdominal aortic aneurysms, now indicated for use in combination with the Heli-FX EndoAnchor system to treat patients with short, hostile aortic neck anatomies.
Prior to receiving the clearance, patients with short infra-renal necks were classified as ineligible for endovascular aneurysm repair, the Fridley, Minn.-based company said. Medtronic estimates that 10-13% of AAA patients have AAA proximal neck anatomies of lower than or equal to 10mm.
“Due to the complex and hostile proximal aortic neck anatomy, this patient population remains a challenge to treat. With minimal time added to the procedure, EndoAnchor fixation has been proven to enhance outcomes and durability, establishing a new treatment approach that addresses this critical patient need,” Anchor registry co-principal investigator Dr. William Jordan Jr. of Emory University School of Medicine said in a prepared statement.
The approval came supported by a short neck cohort from the company’s Anchor registry study exploring real-world use of the Heli-FX endoanchor system, Medtronic said.
A sub-analysis of 70 patients in the registry with proximal AAA neck lengths of lower than 10mm treated with the Endurant and Heli-FX showed a technical success ate of 88.6% and a 97.1% procedural success rate. Data also indicated a 1.9% rate of proximal type Ia endoleaks at 1 year, with only 1 type Ia endoleak resulting in a secondary procedure at 1 year.
No AAA expansions or instances of main body migration were reported at 1 year, as well as no reported AAA ruptures. The average addition to procedure time from the use of the EndoAnchor was 17 minutes, Medtronic said.
“The acquisition of Aptus Endosystems in 2015 demonstrated our deep-rooted commitment to investing in solutions that treat complex aortic disease, and this new indication expansion for the Endurant II/IIs stent graft system is a significant milestone that underscores our promise to improve patient outcomes in partnership with the clinician community. With the use of the Heli-FX Endoanchor system, physicians can now provide durable seal and fixation with a proven stent graft technology to expand care to patients with hostile neck anatomies,” Medtronic aortic biz GM Daveen Chopra said in a press release.
In late September, Medtronic said it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system.