MILPITAS, Calif.--(BUSINESS WIRE)--Elixir Medical, a developer of disruptive technologies to treat cardiovascular disease, announced it will present new clinical data on two innovative platforms, the DynamX Coronary Bioadaptor System and LithiX Hertz Contact Intravascular Lithotripsy (IVL) System at the Transcatheter Cardiovascular Therapeutics (TCT) 2024 annual meeting in Washington, D.C.
At the start of the meeting on Monday, October 28, late-breaking results will be presented from a large population of patients with Acute Coronary Syndrome (ACS) and complex lesion subsets enrolled in the INFINITY-SWEDEHEART Randomized Clinical Trial (RCT).
“The primary endpoint presentation of INFINITY-SWEDEHEART data at ESC 2024 was met with excitement, with positive outcomes confirming bioadaptor’s unique mechanism of action designed to restore hemodynamic modulation of a diseased artery in a broad, real-world patient population. The study not only met its primary endpoint, target lesion failure (TLF) at 12 months, but also demonstrated significant reduction and plateauing of adverse events after six months with bioadaptor compared to DES in a prespecified powered endpoint,” said Motasim Sirhan, CEO of Elixir Medical. “This is the second large RCT to demonstrate such significant reduction and plateauing of events after six months from the procedure compared to current standard of care, DES, confirming the power of restoring vessel function on adverse event reduction for CAD treatment.”
Elixir Medical will also unveil six-month clinical outcomes and optical coherence tomography (OCT) imaging lesion analysis outcomes from the PINNACLE I clinical study evaluating the novel LithiX Hertz Contact Intravascular Lithotripsy technology designed to deliver calcium fragmentation in a broad range of calcium morphologies.
Elixir Medical will also engage with meeting attendees at Booth #2823.
Full list of presentation details:
DynamX Coronary Bioadaptor System
Title: 1-Year And Landmark 6-12 Month Clinical Outcomes Among Patients In Complex Lesion Subsets Treated With Dynamx Bioadaptor Compared To a Contemporary Drug Eluting Stent
From The INFINITY-SWEDEHEART Randomized Clinical Trial
Principal investigator: David Erlinge, M.D., Ph.D., head of the Cardiology Department at Skane University Hospital, Lund, SE.
Session: Late-Breaking Clinical Science – Session 1
Date: Monday, October 28, 2024
Time: 2:00 P.M. - 3:30 P.M. EDT
Location: Main Arena, Ballroom, Level 3
Title: Bioadaptor Technology – Restoring Vessel Function and Improving Long-term PCI Outcomes
Presenters: Dean Kereiakes, M.D., David Erlinge, M.D., Mirvat Alasnag, M.D., Antonio Colombo, M.D., Siu Fung Wong, M.D., Roxana Mehran, M.D.
Session: Case Symposium
Date: Wednesday, October 30, 2024
Time: 2:00 P.M. - 3:15 P.M. EDT
Location: Presentation Theater 4, Innovation & Exhibit Hall (Halls A-C), Lower Level
Title: Six-month Clinical Outcome for STEMI Patients Implanted with DynamX Bioadaptor during PPCI
Presenter: Siu Fung Wong, M.D, United Christian Hospital, Hong Kong
Session: STEMI Outcomes - 3
Date: Tuesday, October 29, 2024
Time: 9:00 A.M. - 9:50 A.M. EDT
Location: Moderated Abstracts Station 1, Innovation & Exhibit Hall (Halls A-C), Lower Level
Title: Adapting the Culotte: From Bench Testing to Complete Longitudinal Analysis of the First-In-Human Culotte Stenting with Double Bioadaptors
Presenter: Chin Wai Lai, M.D., United Christian Hospital, Hong Kong
Session: Novel Coronary Technologies and Approaches
Date: Sunday, October 27, 2024
Time: 2:00 P.M. - 3:30 P.M. EDT
Location: Presentation Theater 1, Innovation & Exhibit Hall (Halls A-C), Lower Level
LithiX Hertz Contact Intravascular Lithotripsy (IVL) System
Title: Contact Intravascular Lithotripsy for Treating Complex Calcific Coronary Lesions: Six-Month and OCT Procedural Imaging Outcomes of the PINNACLE I Clinical Trial
Presenter: Johan Bennett, M.D., Ph.D., FESC., University Hospitals Leuven, Belgium
Session: TCT Innovation 17: Innovations in Percutaneous Coronary Technologies
Date: Wednesday, October 30, 2024
Time: 11:00 A.M. - 12:40 P.M. EDT
Location: Innovation Theater, Innovation & Exhibit Hall (Halls A-C), Lower Level
Title: Mechanistic Effects of Coronary Hertz Contact Intravascular Lithotripsy on Treatment of Calcified Lesions: PINNACLE I OCT Sub-study Procedural Imaging Outcomes
Principal investigator: Johan Bennett, M.D., Ph.D., FESC., University Hospitals Leuven, Belgium
Session: Coronary Calcium and Calcium Modification – 1
Date: Sunday, October 27, 2024
Time: 3:00 P.M. - 3:56 P.M. EDT
Location: Moderated Abstracts Station 1, Innovation & Exhibit Hall (Halls A-C), Lower Level
Title: Safety and Effectiveness of a Novel Intravascular Lithotripsy Device Using the Hertz Contact Stress Mechanism for Calcium Fragmentation: Six-month Outcomes of the PINNACLE I Clinical Trial
Presenter: Valeria Paradies, M.D., head of the research department and cath lab co-director at Maasstad Hospital, Rotterdam, Netherlands
Session: Coronary Calcium and Calcium Modification – 1
Date: Sunday, October 27, 2024
Time: 3:00 P.M. - 3:56 P.M. EDT
Location: Moderated Abstracts Station 1, Innovation & Exhibit Hall (Halls A-C), Lower Level
About the INFINITY-SWEDEHEART Trial
The INFINITY-SWEDEHEART Trial is a prospective, multi-center, single-blind, randomized (1:1), registry-based clinical trial comparing a sirolimus-eluting bioadaptor with a contemporary zotarolimus-eluting stent (DES) in 2,400 patients. The trial is executed in partnership with the ongoing SWEDEHEART registry program in Sweden, a national collaborative research program launched in 2009 to support the evidence-based development of therapies for heart disease. Study management is conducted in collaboration with Uppsala Clinical Research Center (UCR), a non-profit organization providing clinical research services for the development and improvement of health care in Sweden and worldwide.
DynamX Coronary Bioadaptor System
The DynamX bioadaptor is designated by the FDA as a breakthrough technology and is the first coronary implant designed to restore coronary artery hemodynamic modulation as demonstrated by restored vessel pulsatility, compliance, adaptive increase in blood flow volume, and to provide plaque stabilization and regression. With this unique mechanism of action (MOA), the bioadaptor addresses the shortcomings of drug-eluting stents and bioresorbable scaffolds translating to remarkably low clinical event rates that plateau after six months as demonstrated in two randomized controlled trials, BIOADAPTOR-RCT (N=445) and INFINITY-SWEDEHEART (N=2,400).
The DynamX Coronary Bioadaptor System is CE-marked. Not available for sale in the U.S.
About PINNACLE I Trial
The PINNACLE I is a prospective, multicenter, single-arm clinical study evaluating the safety, effectiveness, and performance of the LithiX Hertz Contact Intravascular Lithotripsy (IVL) System for the treatment of calcified lesions. The trial includes 60 patients across five sites in Belgium and the Netherlands. An imaging subset of 30 patients underwent intravascular imaging assessment by OCT. Primary safety and effectiveness will continue to be reported through six months.
About LithiX Hertz Contact Intravascular Lithotripsy System
LithiX Hertz Contact IVL System is a transcatheter device comprising multiple discrete metal hemispheres incorporated on a semi-compliant balloon. The system is designed to deliver calcium fragmentation for a broad range of moderate to severe calcium morphologies by creating multiple discrete focal stress contact points. Using this unique mechanism of action, the LithiX Hertz Contact IVL System aims to accelerate treatment of moderate to severe calcified lesions without requiring an external power source positively impacting PCI procedure workflow.
The LithiX IVL System is not approved for sale in the U.S.
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 and X.
