Reva gets CE mark for drug-eluting bioresorbable scaffold

Reva Medical has secured a CE mark for its drug-eluting bioresorbable coronary scaffold, Fantom. The regulatory green light sets Reva up to start competing with fellow bioresorbable stent pioneers such as Abbott and makers of established metal products for a slice of the cardiology market.

San Diego, California-based Reva secured the CE mark on the strength of data from 117 patients. And it has generated results from a second 123-subject cohort to further make its case. Across the whole data set, Reva saw a 2.1% rate of major adverse cardiac events (MACE) after six months. Most of the events, a mix of heart attacks, cardiac deaths and revascularizations, occurred either in the hospital or toward the end of the time window.

Having secured the CE mark, Reva plans to start selling Fantom in Europe this quarter. Reva has already made enough products to meet this initial demand. In the longer term, Reva envisages more than doubling its its current capacity of 10,000 units a year. To support scale up, a European commercialization drive and work toward approvals in the U.S., India and Japan, Reva is raising money. Management expects to have secured the funding by the end of the month.

That cash will equip Reva to take its place in a growing band of bioresorbable scaffold makers who are seeking to take market share from established metal stent brands. Abbott, Biotronik and Elixir have each gained CE marks for bioresorbable scaffolds over the past seven years. But despite arriving late to the market and lacking the scale of some of its rivals, Reva has ambitious goals for the rollout of Fantom.

“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,” Reva CEO Reggie Groves said in a statement.

The bullishness is underpinned by a belief Fantom is easier to deploy—in part because it is visible on X-rays—and will deliver better outcomes than other bioabsorbable stents. Reva has some evidence to support its confidence. The six-month MACE rate for Fantom compares favorably to data on its CE-marked rivals, which posted figures ranging from 3.3% to upward of 5% when they went through that early test.

That gives Reva a solid starting point, but it will need longer-term data to show Fantom is a safe alternative to well-established metal stents. Worries about the performance of Abbott’s Absorb GT1 bioresorbable vascular scaffold have mounted as investigators have posted longer-term data. Reva executives have said they were unsurprised by the incidence of very late stent thrombosis in patients who received Absorb GT1. And they think Fanton can eliminate long-term safety issues.

Delivering data to back up this belief would go some way to win over payers and physicians who are skeptical about the merits and value of bioresorbable scaffolds. An interim review of Abbott’s Absorb by United Kingdom’s National Institute for Health and Care Excellence published in October found limited evidence to support switching to the device, which, at a list price of £2,200 ($2,736), costs more than the £529 the U.K. typically pays for drug-eluting stents.

Among the healthcare professionals consulted by NICE, one said there is no clearly defined patient group in which Absorb is preferable to metal stents. And another said devices with thinner struts backed up by large data sets on health outcomes are needed to take the technology mainstream.

Reva hopes the CE mark for Fantom is the start of this process.