REVA Medical, a San Diego, California firm, has landed the European CE Mark for its first product, the drug-eluting bioresorbable Fantom coronary scaffold. The device contains sirolimus, aka rapamycin, an immunosuppressant to help prevent restenosis, which is delivered to the implantation area slowly over time. The device itself eventually breaks up and is resorbed by the body.
The Fantom can be delivered via the femoral approach or transradially, depending on the target and the patient’s anatomy. It is delivered and placed very much like permanent stents, allowing cath labs to quickly integrate it into their practice.
REVA is touting that its scaffold is much more radiopaque than the competition, making it more readily visible under X-ray fluoroscopy and about as perceptible as metal stents. This is thanks to REVA’s specially designed proprietary polymer that gives the Fantom its strength and radiopacity.
A bit of detail about the trial that led to the clearance, according to REVA: 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%, 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.