Californian cardio device company REVA Medical, Inc. has initiated patient enrollment with its Fantom™ bioresorbable drug-eluting scaffold.
Fantom™ is a fully bioresorbable sirolimus-eluting coronary scaffold that is designed to dissolve over time, leaving the artery free of a permanent implant and thereby allowing the artery to return to its natural movement, or “vasomotion.”
Fantom is made from REVA’s proprietary polymer that was developed specifically for scaffold performance. The unique properties of REVA’s polymer provide for claimed excellent scaffold strength in a thin-strut design, ease-of-use features like single-step inflation, and complete visibility of the scaffold under x-ray, an attribute unique to REVA among bioresorbable scaffolds.
The first patient implants were performed by Dr. Alexandre Abizaid, Director of Invasive Cardiology at Institute Dante Pazzanese of Cardiology in Sao Paulo, Brazil. Dr. Abizaid is coprincipal investigator for the Fantom clinical trial program.
Jeff Anderson, REVA’s Senior Vice President of Clinical and Regulatory Affairs was present for the implants. “During these first procedures, the unique features of the Fantom scaffold were evident,” stated Mr. Anderson. “The scaffold was easily delivered and the procedure was aided by the visibility of the scaffold under x-ray, a feature that we believe provides physicians with a valuable tool for confirming proper placement during implant.”
“The initiation of our Fantom clinical program as set forth in our recent communications is an important and valuable milestone for the Company,” commented REVA’s Chairman and Chief Executive Officer, Bob Stockman.
Source: Reva Medical, Inc.