- 12-month clinical and imaging data from first multicenter, international, randomized controlled trial of DynamX® Bioadaptor vs. Resolute OnyxTM to be presented Wednesday, May 17.
- Elixir Medical’s DynamX Bioadaptor goes beyond traditional caged tube drug-eluting stents (DES), or the promise of bioresorbable scaffolds (BRS), and is designed to restore flow, release vessel motion and return normal function to the cardiac vessel.
Elixir Medical, a developer of breakthrough cardiovascular technologies, today announced that data from its Bioadaptor RCT randomized controlled trial (RCT), an international, multicenter, single-blind study enrolling 445 patients will be presented at the EuroPCR conference in Paris.
The data compare the DynamX Coronary Bioadaptor Scaffold in a 1:1 randomization to Resolute Onyx, a leading drug-eluting stent (DES).
“Advancements in DES technology have been incremental over the last 20 years and have improved only the first-year outcomes. We continue to see annual 2-3% non-plateauing adverse events rates attributable to permanent caging of the vessel, while once promising Bioresorbable Scaffold (BRS) technology has failed to demonstrate restoration of function or benefit over DES in randomized trials,” said Motasim Sirhan, CEO of Elixir Medical.
“Designed to address the shortcoming of DES and BRS, Elixir’s DynamX Bioadaptor has the potential to transform the way we think about percutaneous coronary intervention (PCI) and the profound benefits of restoring vessel motion and function.”
“We look forward to sharing the data from the Bioadaptor RCT study as we continue to build a growing body of evidence.”
Elixir Medical will also exhibit at booth N4 and is hosting a case-in-point symposium featuring world-renowned interventional cardiologists, Antonio Colombo, M.D., Milan, Italy; Shigeru Saito, M.D., Kamakura City, Japan; Holger Nef, M.D., Giessen, Germany; Stefan Verheye, M.D, Antwerp, Belgium; Johan Bennett, M.D., Ph.D., Leuven, Belgium; and Teguh Santoso, M.D., Jakarta, Indonesia, who will provide a DynamX Bioadaptor technology overview and share real world experience and case studies.
In recent publications of 9-month and 12-month clinical and imaging follow up from the Mechanistic trial, DynamX Bioadaptor demonstrated release of the vessel and restoration of the vessel motion and function.
The Bioadaptor RCT trial evaluates in a randomized controlled design the potential ability and implications of the Bioadaptor to return vessel motion and function compared to DES in a broader patient population.
