New data for Medtronic’s Heli-FX EndoAnchor
Medtronic (NYSE:MDT) presented data from a trio of sub-group analyses from its 2,000-patient Anchor registry study of the Heli-FX EndoAnchor it acquired from Aptus Endosystems for $110 million last year.
The device is designed to provide an anchor for a variety of stent grafts and is aimed at treating patients with “hostile” or challenging aneurysm anatomies.
The Fridley, Minn.-based medical device titan said Dr. Bart Muhs of Middletown, Conn.’s The Vascular Experts presented 1-year data from 99 patients treated with the device and an approved stent graft, compared with patients who were not implanted with EndoAnchor implants. The cohorts were matched using 19 baseline variables, Medtronic said.
The EndoAnchor group showed a statistically significant difference in sac regression at 28.6%, compared with 20.3% for the control group. Although not statistically significant, the analysis also showed differences in proximal neck dilation (98.4% for the EndoAnchor-treated group vs. 94.9% for the control arm) and freedom from Type 1a endoleaks (97.0% vs. 94.1%), the company said.
“This propensity-matched data from the Anchor registry shows that the Heli-FX EndoAnchor system improves patient outcomes based on key measures of effectiveness,” Muhs said in a prepared statement. “Our analysis reflects real-world clinical experience, and provides the next level of clinical evidence supporting this EndoAnchor system in patients with complex, hostile abdominal aortic aneurysms.”
Emory University’s Dr. William Jordan also presented at the Veith conference, revealing data from 604 patients with hostile “short-neck” aneurysms. The analysis divided the patients into 3 groups: A 314-patient cohort treated with the Heli-FX EndoAnchor and EVAR; a 123-patient cohort treated prophylactally with the device to solve endoleaks immediately after EVAR; and a 167-patient cohort treated with Heli-FX EndoAnchor during a follow-up after EVAR.
Analyses after 1 and 2 years showed the following:
|Outcome||Therapeutic primary||Prophylactic||Therapeutic revision|
|Endoleaks 1 year||1.4%||0.6%||19.2%|
|Endoleaks 2 years||2.9%||0.0%||11.1%|
|Positive sac regression 1 year||43.1%||45.6%||16.9%|
|Positive sac regression 2 years||51.4%||61.2%||37.9%|
|Freedom from secondary procedures 1 year||97.9%||95.9%||84.8%|
|Freedom from secondary procedures 2 years||92.9%||92.1%||79.9%|
|Freedom from aneurysm-related mortality 1 year||98.4%||98.4%||96.5%|
|Freedom from aneurysm-related mortality 2 years||98.4%||98.4%||92.6%|
“These data further support the added security and durability of the Heli-FX EndoAnchor system we are seeing in clinical practice,” Jordan said in the statement. “With low rates of Type Ia endoleaks and re-intervention rates, positive sac regression and freedom from ARM rates, EndoAnchor implants allow for safe and effective treatment of more complex anatomies, both prophylactically and in conjunction with treatment of a post-EVAR complication, such as a migration or Type Ia endoleak.”
Medtronic said Dr. Apostolos Tassiopoulos of New York’s Stony Brook University Medical Center made a related presentation of 1-year data on peri-operative neck dilation showing that the device appears to offer protection against neck dilation.
“We are excited to see the continued, positive data from the Anchor registry that demonstrate the strength and durability of our Heli-FX EndoAnchor system when used with EVAR in patients with hostile AAA anatomy,” aortic general manager Daveen Chopra said in prepared remarks. “Following our acquisition of Aptus Endosystems and its Heli-FX and Heli-FX thoracic EndoAnchor systems last year, this technology further reflects our commitment in providing solutions for challenging patients with complex aortic disease based on real-world, rigorous clinical data.”