FDA Nod for Bioadaptive Cardiac Implant
Image credit: Elixir Medical
California-based Elixir Medical has been granted Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its novel bioadaptive implant used in the treatment of cardiovascular disease.
The DynamX Sirolimus-Eluting Coronary Bioadaptor System, which already has European CE marking, is designed to return diseased heart vessel to a more normal physiology and function across three key phases.
- Following implantation, the helix-shaped strands of the bioadapter are designed to stay “locked”, to establish the patient’s maximum flow rate and restore blood flow.
- Once surrounded with tissue and its polymer coating is resorbed, the device separates to enable growth and adaptation of the heart vessel to preserve the established blood flow.
- In a final phase, the separated strands of the device help to return viability and haemodynamic modulation of the vessel across a range of factors including pulsatility, adaptive blood flow volume and plaque stabilisation and regression.
“We very much appreciate FDA’s breakthrough designation recognition of the bioadaptor technology,” said Elixir Medical CEO, Motasim Sirhan in a press statement.
“We look forward to working with FDA, Centers for Medicare & Medicaid Services, and respective physician societies to bring this technology to US patients as soon as possible to elevate the standard of care for cardiovascular disease treatment.”
For more information, refer to the press release via Elixir Medical.
