REVA Medical secures early CE Mark approval for novel coronary artery treatment

Medical device maker REVA Medical (ASX: RVA) says it has developed a significant technical improvement upon existing technology for surgical operations, specifically in procedures treating coronary artery disease.

REVA’s Fantom Encore, a “bioresorbable” product that allows arteries to heal more efficiently after surgical procedures, has also received an official stamp of approval in the form of the CE Mark, a regulatory milestone that allows Fantom Encore to be marketed and sold in Europe.

REVA says that it has seen its Fantom Encore “scaffold” successfully implanted by Dr Matthias Lutz at the Universitätsklinikum Schleswig-Holstein in Kiel, Germany.

The feat is a world first for REVA and means the growing biotech company will have the thinnest strut profile of any available bioresorbable scaffold in the 2.5-millimetre diameter size.

According to Dr Lutz, Reva’s product is a viable improvement on existing technology: “My experience with Fantom Encore was a successful implantation procedure, and it was easy to see with x-ray. Bioresorbable scaffolds have the potential to improve long-term outcomes compared with metal drug-eluting stents and are an important treatment option for my patients.”

REVA’s proprietary “tyrosine-derived polymer” was designed specifically for vascular applications and has the potential for improved ease-of-use and vessel healing, which are critical for the broader commercial adoption of the technology.

According to REVA, its Fantom and Fantom Encore medical devices are “sirolimus-eluting bioresorbable scaffolds,” developed as an alternative to metallic stents for the treatment of coronary artery disease.

Such scaffolds are installed during medical procedures and are typically made from metal. REVA’s Fantom products are made from a material that can be broken down by the human body and forego costly and damaging side-effects that can sometimes occur.

According to REVA, Fantom Encore restores blood flow and supports the artery through the healing process, before being “resorbed” from the body over a period of time.

This resorption is intended to allow the return of natural movement and function of the artery in a less invasive and more efficient way for patients.

The 2.5-millimetre Fantom Encore polymer-based product is expected to make its commercial debut “at select centres”, while it goes on to pursue similar CE Mark approvals for 3.0 and 3.5-millimetre versions of the product.

REVA says it expects to launch the entire Fantom Encore product line later this year, with commercial adoption forecast for the near-term.

“Approval of Fantom Encore is a significant milestone in bioresorbable polymer and scaffold technology. REVA developed a novel polymer, Tyrocore, and then used it to create a bioresorbable scaffold with the most advanced features available: x-ray visibility and a 95-micron profile,” said Reggie Groves, CEO of REVA Medical.

“To date, we have received very positive feedback from our Fantom customers. We expect that Fantom Encore will deliver the next level of performance as we expand commercialisation of our bioresorbable scaffolds,” said Mr Groves.