DynamX Sirolimus Eluting Coronary Bioadaptor System - Drug-eluting coronary artery stent, biodegradable-polymer-coated

Intended purpose

The DynamX bioadaptor is a permanent implant incorporating the ancillary drug substance, Sirolimus, and is intended to improve coronary luminal diameter in patients with symptomatic ischemic heart disease. The DynamX SECBS is indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo native coronary artery lesions with reference vessel diameters between 2.0 – 4.0mm and ≤ 44mm in length. The bioadaptor is intended as a permanent implant.

Functional description

Pre-mounted balloon expandable CoCr bioadaptor with uncaging elements along length which uncage vessel after bioresorbable polylactide polymer coatings resorb. Sirolimus delivered via the polymer allows sustained release in approx. 4 weeks. Rapid-exchange delivery system includes a nylon-blend balloon & distal shaft & stainless steel hypotube in proximal shaft. Total working length 140cm. 2 radiopaque balloon markers. 2 proximal markers to indicate relative position to guiding catheter tip.