Reva Medical looks to CE Mark for Fantom scaffold

Reva Medical (ASX:RVA) said today it completed its submission for CE Mark approval of its Fantom sirolimus-eluting bioresorbable coronary scaffold following the completion of a clinical data analysis and testing.

The San Diego, Calif.-based company said it is hopeful it will receive CE Mark approval by December 31, 2016.

Data from a 117-patient cohort from its Fantom II study was used to support the application, reporting a 2.6% rate of major adverse cardiac events at 6 months, according to a press release.

Late lumen loss in-scaffold at 6 months was 0.25mm, and in-segment LLL was 0.17mm, which the company said compares “favorably to the rates of commercially available competitive bioresorbable scaffolds and drug-eluting stents.”

Patients in the trial will be followed for 5 years, Reva Medical said, with an additional 123 patients in a separate cohort set to undergo clinical safety evaluations at 6 months and invasive imaging assessments at 9 months, with evaluations ongoing into the 1st quarter of 2017.

Data from both cohorts is slated to be presented at the Transcatheter Cardiovascular Therapeutics conference in late October.

In February, Reva updated on its Fantom II trial, which has reached its target enrollment of 110 patients for its 1st cohort, and announced an incoming $11.4 million through a sale of shares to Goldman Sachs International.

The 110 patients make up the 1st cohort of the company’s trial investigating its Fantom scaffold, and bring the total enrollment up to 227 patients. Patients in the 1st cohort are undergoing a 6-month long imaging assessment and data from the subset will be used in the company’s CE Mark application.

Data from patients in the 2nd cohort will be used to provide clinical evidence regarding the use of Fantom to treat coronary artery disease, and will be used for market support and other commercial purposes.

Reva also announced that Goldman Sachs International has indicated it plans to exercise an option to purchase up to 4.4 million shares of common stock, bringing in an additional $11.4 million for the company.

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