Medtronic posts data on stent grafts and venous closure systems

Dive Brief:

Medtronic presented new data Wednesday on its VenaSeal Closure System and Endurant II/IIs stent graft system.
The two- and five-year data on the devices in endosuture aneurysm repair and the treatment of chronic venous disease suggest efficacy seen earlier in the studies is durable.
Medtronic also shared early clinical data on a lower-profile version of its Valiant Captivia thoracic stent graft system, which the company said was designed to treat underlying pathologies while minimizing potential impact to fragile aortic walls.

Dive Insight:

Medtronic arrived at the 2019 Charing Cross Symposium in London with new data on several of its devices, including the VenaSeal closure system in the treatment of chronic venous disease. A pivotal trial comparing VenaSeal to Medtronic's ClosureFast radiofrequency ablation device finished years ago, leading to FDA approval in 2015 and the use of the product in more than 100,000 procedures.

Since then, Medtronic has continued to monitor early recipients of the device. The data presented this week show the aggregate complete closure rate of the great saphenous vein in patients with five years of follow-up is 95%.

VenaSeal continues to perform as well as ClosureFast in terms of vein closure and deliver quality of life improvements, Medtronic announced. The follow-up data give the company more evidence to support its argument that VenaSeal is an effective treatment for varicose veins that is free from the risk of nerve damage and post-treatment bruising that affect other techniques.

Elsewhere at the symposium, Medtronic presented a two-year analysis of abdominal aortic aneurysm (AAA) patients with short aortic necks. These patients were treated with Endurant and the Heli-FX EndoAnchor system.

Among the first 38 patients to reach two-year imaging follow-up, one patient required a proximal neck-related reintervention. The rate of aneurysm-related mortality was less than 6% and no patients suffered AAA ruptures or stent graft main body migrations.

Medtronic presented earlier data on another stent graft system, Valiant Navion. The thoracic stent graft system is a low-profile variant of Medtronic's Valiant Captivia that the company is testing in a clinical trial in 100 thoracic aortic aneurysm and penetrating atherosclerotic ulcer patients.

After 30 days, the rates of perioperative mortality and secondary procedures were both 2%. Around 1% of subjects suffered a Type Ia endoleak, an event defined by the leak of blood back into an aneurysm sac.