Reva Medical (ASX:RVA) said yesterday that it won CE Mark approval in the European Union for its Fantom sirolimus-eluting bioresorbable coronary scaffold.
The Fantom scaffold is the San Diego, Calif.-based company’s 1st commercial product. Reva said it plans to begin selling the product in Europe this quarter.
“CE Mark approval for Fantom is a major milestone for the company. It is the culmination of years of effort,” CEO Reggie Groves said in prepared remarks. “As the patient population becomes increasingly acquainted with the appeal of bioresorbable scaffolds in general, versus metal stents, we believe they will come to ask for Fantom by name, based on our positive data and the increasing preference for Fantom that we expect leading clinicians will develop over time.”
Data from the company’s Fantom II 240-patient trial were used to support the CE Mark application, Reva said. The study’s major adverse cardiac event rate through 6 months was 2.1%, which compared favorably to commercial 1st-gen bioresorbable scaffolds, according to Reva. The company said it plans to publish additional data in May and October this year.
Reva is also pursuing private funding to support the commercial launch of Fantom, as well as its ongoing needs, including clinical trials and new product feasibility work. The company said it expects its financing to close before the end of this month.
Reva is just the latest entrant into the European biodegradable coronary stent market, joining Abbott (NYSE:ABT), Biotronik and Elixir Medical.
Abbott won CE Mark approval for its Absorb stent in 2011 and 3 years later, Elixir was granted European regulatory approval for its fully-bioresorbable coronary scaffold, DESolve. Biotronik won CE Mark approval for its Magmaris stent last year.
Abbott’s fully-biodegradable Absorb stent won FDA approval in July last year, making it the 1st fully-dissolving stent commercially available in the U.S. for the treatment of coronary artery disease.