Reva Medical expands commercial footprint in Europe while it looks to prove bioresorbable stent benefits

SAN FRANCISCO—Reva Medical has expanded its commercial operations to seven additional European countries through four new regional distribution partnerships, while it looks to build up clinical evidence for its bioresorbable stents.

The San Diego-based company will make moves into Russia, Poland, the Czech Republic, Slovakia, Lithuania, Latvia and Estonia, which together represent a $290 million medical device market with over 350,000 percutaneous interventions for coronary artery disease performed each year, Reva said in a statement (PDF).

Similar to Reva’s existing deals in Italy and Turkey, each distributor will be responsible for all sales, marketing, customer training and support in their respective regions. The company plans on beginning commercialization within the next 3 to 12 months, following local approvals and registrations, and the training of distributor staff.

Last year, Reva received CE marks for its Fantom Encore bioresorbable stent with thinner struts in coronary artery disease, as well as for its flexible MOTIV drug-eluting scaffold for peripheral artery disease below the knee.

The Fantom stent. (Reva Medical)

Those came after medtech heavies Abbott and Boston Scientific scrapped their own bioresorbable stent programs—with Abbott seeing low sales and safety concerns—leaving Reva as one of the only developers in the space, and with the responsibility to convince physicians of the benefits of the product compared to traditional metal stents.

“I fundamentally believe that metal is a great solution if you have coronary artery disease, but that bioresorbable is a better solution,” said Reva CEO Reggie Groves at the J.P. Morgan Healthcare Conference.

“You only need the stent for three, four or five months, and if you leave a foreign body in there—particularly if you're under 65 years old—you've got a long life expectancy,” Groves said. “Or God forbid you have a nickel allergy. You just weren’t meant to have a permanent implant in there.”

Currently Reva is targeting early adopters in its commercial launch, and is preparing for a randomized clinical study in Europe.

The big difference with the latest Fantom Encore stent is the thickness of its polymer struts: At 95 microns, it’s closer to the size of Abbott’s 83-micron Xience metal drug-eluting stent, and much thinner than Abbott’s previous 150-micron bioresorbable scaffold.

“We need to get more clinical evidence to undo the damage that was done by Abbott's clinical evidence,” Groves said.

“We need to make sure we have the right physicians doing implants, that they're trained to do it right, that they're trained to select patients properly, and to enroll them in our clinical studies—so that we continue to build the clinical evidence to show that not only are we better than absorb, but in the long run we're better than drug-eluting metal stents.”