Reva finishes CE trial enrollment for drug-eluting scaffold

Reva Medical (ASX:RVA) said it finished enrollment in its CE clinical trial of its Fantom siolimus-eluting bioresorbable scaffold for patients being treated for coronary artery disease.

Data from the 110-patient Fantom II trial will be used for the company’s CE Mark application in the European Union, which the company said it is hopeful to submit in mid 2016 at the 6-month point for the study.

“Enrollment of these 110 patients represents a significant accomplishment for the company. It moves us one step closer to our goal of commercializing Fantom, which we believe offers the performance and ease-of-use features that will enable physicians to provide the best possible care for their patients,” CEO Reggie Groves said in prepared remarks.

The scaffold is designed to restore blood flow in CAD patients and be reabsorbed by the body to allow the vessel to heal and begin to move naturally, the San Diego, Calif.-based company said.

“I have been very pleased with how easy Fantom is to implant. The delivery to the target lesion has been successful in our cases and the single-step inflation reduces the overall procedure time,” lead investigator Dr. Didier Carrié of Toulouse, France’s Hospital Rangueil said in a press release.

“The ability to visualize the scaffold under x-ray sets Fantom apart from other bioresorbable scaffolds. This unique feature will make it easier for physicians to incorporate bioresorbable scaffold use into their practice,” lead investigator Dr. Bernard De Bruyne of Aalst, Belgium’s Cardiovascular Center said in a prepared statement.

Reva Medical said it will present updated information from the trial at the Transcatheter Cardiovascular Therapeutics Conference later this month in San Francisco.

In April, Reva Medical said it would expand a trial of its Fantom bioabsorbable drug-eluting stent to Europe, a few months after launching the study in Brazil.

The 1st implantation in Europe for the Fantom II clinical trial took place in Denmark, the company said. Fantom is delivered through either the femoral artery in the groin or the radial artery in the wrist.

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