REVA Medical, Inc. is has announced it has received CE Mark approval for its Fantom drug-eluting bioresorbable coronary scaffold, which offers multiple and substantial performance advantages over first-generation scaffolds on the market today. Fantom is REVA’s first commercial product.
CE Marking allows for commercial sales in Europe and other countries that recognize the mark. With the approval, REVA will commence selling in selected centers in Europe this quarter. Initial quantities of the product have been manufactured and are immediately available to support commercialization.
“CE Mark approval for Fantom is a major milestone for the company,” says Chief Executive Officer Reggie Groves. “It is the culmination of years of effort. 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.”
(Image credit: REVA Medical)
Data from patients enrolled in the Company’s FANTOM II clinical trial were used to support the CE Mark application. The trial enrolled a total of 240 patients between March 2015 and March 2016. The Major Adverse Cardiac Event (MACE) rate through six months for all 240 patients is 2.1 percent, which compares favorably to commercial first-generation bioresorbable scaffolds. The Company continues to follow and evaluate patients and plans additional data releases at major industry conferences in May and October of this year.
As previously announced, the company is currently pursuing a private financing to support its commercial launch of Fantom and its ongoing operating and capital needs, including follow-on clinical trials and new product feasibility work. The financing is anticipated to close before month end.
