Elixir Medical has begun patient enrolment in an international pivotal clinical study to assess the safety and efficacy of its DESolve novolimus-eluting bioresorbable coronary scaffold system for treating coronary blockages.
The DESolve system features a poly-L-lactide-based polymer scaffold to support the coronary artery while delivering the novolimus.
The multicentre, prospective DESolve Nx study will enrol 120 patients at up to 15 centres in Germany, Belgium, Poland, Brazil and New Zealand.
The primary safety endpoint will be cardiac death, target vessel myocardial infarction and clinically-indicated target vessel revascularisation, and the angiographic endpoint includes in-stent late lumen loss at six months for all patients as assessed by quantitative coronary angiography.
Elixir Medical CEO Motasim Sirhan said the company will provide physicians with multiple sizes of the DESolve System to address broad patient population needs.