MILPITAS, Calif.--(BUSINESS WIRE)--Elixir Medical, a developer of transformative technologies to treat cardiovascular and peripheral disease, announced it will present long-term two-year clinical results from its BIOADAPTOR Randomized Controlled (1:1) Trial (RCT), an international, single-blind study comparing the novel DynamXⓇ Coronary Bioadaptor System designed to restore coronary artery hemodynamic modulation and vessel function, compared with a standard of care drug-eluting stent (DES) therapy, as a late-breaker session at EuroPCR 2024 in Paris on May 14.
“There remains a large unmet need for transformative technology in cardiovascular intervention to address limitations of coronary artery disease (CAD) treatments such as maintaining the established artery flow lumen, restoring vessel hemodynamic modulation, and stabilizing or regressing plaque to deliver durable and incremental clinical benefit. In the absence of restoring artery function, today we see 20% MACE within 5 years1 and 50% by 10 years2 after PCI attributable to non-plateauing annual adverse events with DES,”3 said Motasim Sirhan, CEO of Elixir Medical. “We are very pleased with our 12-month data from the BIODAPTOR RCT study, which demonstrated restoration of vessel motion and function with better effectiveness than standard of care, DES, and we are thrilled to unveil the two-year clinical outcomes to solidify the strong body of clinical evidence supporting the DynamX Bioadaptor in delivering sustained superior clinical outcomes for patients.”
Elixir Medical will also unveil primary clinical, angiographic, and OCT imaging outcomes from the PINNACLE I clinical study evaluating its novel LithiXTM calcium fragmentation technology based on Hertz Contact Intravascular Lithotripsy. Featured as an Innovation Session presentation, the clinical results are intended to demonstrate safety and efficacy of Elixir’s lithotripsy technology designed to simplify treatment of a broad range of complex calcified lesions while advancing safety and efficacy of calcium modification.
Additionally, Elixir Medical will share late-breaking 12-month outcomes of its TRx site-specific antithrombotic therapeutic from the DESyne BDS Plus RCT, a prospective, multicenter, single-blind study evaluating the safety, effectiveness, and performance of the world’s first triple-drug site-specific antithrombotic therapy (TRx) on a DES compared to DESyne X2 Drug-Eluting Coronary Stent System in the treatment of de novo native coronary artery lesions.
Full list of presentation details:
Late-breaker presentation details: New coronary devices (DES / BRS / DCB)
Title: “Site-specific antithrombotic therapy: DESyne BDS Plus study 12-month outcomes”
Principal investigator: Alexandre Abizaid, M.D., Ph.D., of The Instituto Dante Pazzanese de Cardiologia, São Paulo, Brazil
Date: Tuesday, May 14, 2024
Time: 15:15 - 16:45 CEST
Location: Theatre Havane
Late-breaker presentation details: New coronary devices (DES / BRS / DCB)
Title: “Two-year clinical outcomes of the BIOADAPTOR RCT study”
Principal investigator: Shigeru Saito, M.D., director of the Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital, Kanagawa, Japan
Date: Tuesday, May 14, 2024
Time: 15:15 - 16:45 CEST
Location: Theatre Havane
Innovations / CV pipeline session: Other coronary interventions
Title: “Hertz contact intravascular lithotripsy: PINNACLE I study primary outcomes”
Presenter: Stefan Verheye, MD, PhD, senior interventional cardiologist at Antwerp Cardiovascular Center, ZNA Middelheim, Antwerp, Belgium
Date: Thursday, May 16, 2024
Time: 14:45 - 16:15 CEST
Location: Room 352A
E-Poster: Coronary interventions
Title: “INFINITY-SWEDEHEART: an innovative registry-based RCT comparing DynamX bioadaptor to DES”
Presenter: David Erlinge, M.D., Ph.D., head of the Cardiology Department at Skane University Hospital, Lund, SE.
Location: The Poster Lab - Level 3
Case in point session
Title: “Cracking the calcium code - Novelty and utility of Hertz Contact intravascular lithotripsy” with discussion on the company’s novel HC-IVL system and human experience
Presenters: Stefan Verheye, M.D., Roxana Mehran, M.D., Valeria Paradies, M.D., Stefano Galli, MD, Johan Bennett, M.D.
Date: Wednesday, May 15th, 2024
Time: 13:30 to 14:15 CEST
Location: Room 251
Case in point session
Title: “Restoring vessel physiology drives outcomes - The Bioadaptor experience” which will highlight the bioadaptor’s unique mechanism of action and real-world global clinical experience with the technology
Presenters: Flavio L. Ribichini, M.D., Johan Bennett, M.D., Mirvat Alasnag, M.D., Michal Hawranek, M.D., Ganapathi Palaniappan, M.D., Anthony Siu-Fung Wong, M.D
Date: Thursday, May 16, 2024
Time: 13:30 to 14:15 CEST
Location: Room 243
About BIOADAPTOR RCT Trial
The BIOADAPTOR RCT is an international, single-blind, randomized controlled (1:1) trial comparing a sirolimus-eluting Bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients. Both arms had large randomized multi-modality imaging subgroups of 100 patients each powered to document standard effectiveness benchmarks of establishing and maintaining artery flow lumen measured by percent diameter stenosis (%DS) and late lumen loss (LLL), and the new effectiveness benchmarks of restoring artery hemodynamic modulation, including pulsatility, vessel compliance, and adaptive flow volume. Clinical follow-up will continue through five years.
BIOADAPTOR RCT trial is the third trial of Elixir Medical’s robust DynamX Bioadaptor clinical evidence program consisting of nine company-sponsored and investigator-initiated studies involving over 9,000 patients, including INFINITY SWEDEHEART RCT (n=2400) and a global BIO-RESTORE registry with a target enrollment of up to 5,000 patients.
About PINNACLE I Trial
The PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating safety, effectiveness, and performance of the LithiX Hertz Contact Lithotripsy Catheter for the treatment of calcified lesions. The trial includes up to 60 patients across 5 sites in Belgium and Netherlands. Angiographic imaging outcomes of all 60 patients and a subset of 30 patients by OCT are scheduled to undergo independent core lab analysis. Primary safety and effectiveness outcomes will be reported at 30 days and 6 months.
About the DESyne BDS Trial
The DESyne BDS Plus Randomized Clinical Trial (RCT) is a prospective, multicenter, single-blind study evaluating the safety, effectiveness, and performance of the TRx site-specific antithrombotic therapeutic on DESyne BDS Plus Triple Drug-Eluting Coronary Implant compared to DESyne X2 Drug-Eluting Coronary Stent System in the treatment of de novo native coronary artery lesions. The trial includes 202 patients across 14 sites in Europe, New Zealand and Brazil. An imaging subset of 58 patients had angiographic and optical coherence tomography (OCT) assessment completed in the first six months. Data collection will continue through three years.
About Elixir Medical
Elixir Medical Corporation, a privately-held company based in Milpitas, California, develops disruptive platforms to treat coronary and peripheral artery disease. Our transformative technologies have multiple applications across the cardiovascular space capable of delivering improved clinical outcomes for millions of patients. Visit us at www.elixirmedical.com and on LinkedIn.
References:
1. Iqbal et al. Final 5-Year Report of the RESOLUTE All-comers Trial. Circ Cardiovasc Interv. 2015.
2. Kufner et al. ISAR-TEST 4 Trial. Circulation, 2019.
3. Madhavan MV et al. J Am Coll Cardiol 2020;75:590-604.
