Two-Year Data Presented for ESAR Combining Medtronic's Endurant Stent Graft and Heli-FX EndoAnchor Systems
April 17, 2019—Medtronic announced the presentation of new data for endosuture aneurysm repair (ESAR) in patients with abdominal aortic aneurysms (AAAs) with the Endurant II/IIs stent graft system (Medtronic) in combination with its Heli-FX EndoAnchor (Medtronic) implants in challenging anatomies. Frank R. Arko III, MD, presented the data at the Charing Cross Symposium, held April 15–18 in London, United Kingdom.
The preliminary 2-year subanalysis data from the global ANCHOR registry evaluated the real-world safety, durability, and effectiveness of ESAR with the combined Endurant and Heli-FX approach to treat patients with AAAs and short aortic necks. This was the first presentation of these subanalysis results from the multicenter, multiarm, prospective, postmarket ANCHOR registry, noted the company.
According to Medtronic, the findings from the first 38 patients to reach 2-year imaging follow-up included:
- 94.3% freedom from aneurysm-related mortality
- 95.5% freedom from secondary endovascular procedure
- Proximal neck-related reintervention in one patient
- No new or persistent type Ia endoleaks, per core lab assessment
- AAA sac regression > 5 mm in 64.7% of Endurant plus Heli-FX short-neck patients and no AAA sac enlargement
- No AAA ruptures or stent graft main body migrations
In Medtronic's announcement, Dr. Arko commented, "By using an ESAR approach with the Endurant stent graft and the Heli-FX EndoAnchor system, physicians are able to safely and effectively treat a wider range of patients with short aortic neck anatomies, independent of renal stenting. At 2 years, the preliminary data also demonstrate that 100% of sacs are either shrinking or stable—an indicator of endovascular aneurysm repair durability."