– 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 –
MILPITAS, Calif.–(BUSINESS WIRE)–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. 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,” said Motasim Sirhan, CEO of Elixir Medical. “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.
Late-breaker presentation details:
Title: “12-Month primary endpoint outcomes of the BIOADAPTOR RCT”
Principal Investigator: Shigeru Saito, M.D., Director of the Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kanagawa, Japan
Date: Wednesday, May 17, 2023
Time: 14:45 CEST
Location: Room Maillot
Title: “Restoring vessel physiology and function with DynamX Bioadaptor – the holy grail of PCI”
Anchorperson: Antonio Colombo, M.D.
Spokesperson: Johan Bennett, M.D.
Discussants: Shigeru Saito, M.D., Holger Nef, M.D., Stefan Verheye, M.D., Teguh Santoso, M.D.
Date: Wednesday, May 17, 2023
Time: 13:30 CEST
Location: Room 252B
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.
About the BIOADAPTOR RCT Trial
The BIOADAPTOR RCT is an international, single-blinded, randomized controlled (1:1) trial compared a sirolimus-eluting Bioadaptor with a contemporary zotarolimus-eluting stent, a drug-eluting stent, in 445 patients. An imaging subset of 100 patients had angiographic and intravascular ultrasound assessments, and 20 patients additionally had optical coherence tomography. Data collection will continue through five years.
About DynamX Coronary Bioadaptor Scaffold
DynamX Bioadaptor is the first coronary scaffold technology designed to unlock the scaffold, uncage the vessel, and restore and sustain normal vessel motion and function after percutaneous coronary intervention (PCI) by maintaining dynamic support of the diseased vessel after its uncaging. With this unique mechanism of action (MOA), it addresses the shortcomings of drug eluting stents and bioresorbable scaffolds (BRS) while delivering low clinical event rates.
The DynamX Coronary Bioadaptor System is CE marked. Not available for sale in the USA.
About Elixir Medical
Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. The company’s technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit Elixir at www.elixirmedical.com and on LinkedIn and Twitter.
Erich Sandoval, Health+Commerce
Email: [email protected]