Elixir Medical To Present Randomized Clinical Dataset Featuring World’s First Triple Drug-Eluting Coronary Implant Eluting Two Anticoagulants and Sirolimus at TCT 2023

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The data compare DESyne BDS Plus, the world’s first triple drug-eluting stent with local anticoagulation delivery technology using two anticoagulants (rivaroxaban and argatroban) and an anti-proliferative mTOR inhibitor (sirolimus) to a second-generation durable polymer DES.

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星期四, 十月 5, 2023
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Science, Cardiology, Biotechnology, Research, Health, Medical Devices, Health Technology, Clinical Trials, Elixir, Exhibition, Death, Medicine, Innovation, Coronary artery disease, DAPT, Risk, Moscone Center, PCI, Anticoagulant, Percutaneous coronary intervention, Data collection, Abstract (summary), Novel, OCT, Clinical study design, Automotive Supplier Innovation Program, Sirolimus, Rivaroxaban, Patient, RCT, Diagnosis, TCT, Pharmaceutical industry, Fine chemical
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UNITED STATES, NORTH AMERICA, CALIFORNIA, NEW ZEALAND, BRAZIL, EUROPE, SAN FRANCISCO
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摘要
Key Points: 
  • The data compare DESyne BDS Plus, the world’s first triple drug-eluting stent with local anticoagulation delivery technology using two anticoagulants (rivaroxaban and argatroban) and an anti-proliferative mTOR inhibitor (sirolimus) to a second-generation durable polymer DES.
  • “Stent thrombosis after percutaneous coronary intervention (PCI), though rare, is a severe complication with death or heart attack risk of up to 50% after the event.
  • An imaging subset of 60 patients had angiographic and optical coherence tomography (OCT) assessment completed at six months.
  • Elixir Medical is also hosting the scientific symposium, “Innovation for PCI: Improved outcomes require disruption” featuring a panel of speakers including Robert W. Yeh, M.D., Mirvat Alasnag, M.D, Ignacio Cruz-Gonzalez, M.D., Ph.D., Roxana Mehran, M.D.


Elixir Medical, a developer of innovative cardiovascular technologies, announced it will present primary endpoint and 6-month data from its DESyne BDS Plus Randomized Clinical Trial (RCT), a prospective, multicenter, single-blind study, as part of The Innovation Program at the Transcatheter Cardiovascular Therapeutics (TCT) conference in San Francisco. The data compare DESyne BDS Plus, the world’s first triple drug-eluting stent with local anticoagulation delivery technology using two anticoagulants (rivaroxaban and argatroban) and an anti-proliferative mTOR inhibitor (sirolimus) to a second-generation durable polymer DES.

“Stent thrombosis after percutaneous coronary intervention (PCI), though rare, is a severe complication with death or heart attack risk of up to 50% after the event. Dual antiplatelet therapy (DAPT) has played an integral role in keeping stent thrombosis rates low, but requires patient compliance for a minimum of six months and is associated with an increased risk of major bleeding,” said Motasim Sirhan, CEO of Elixir Medical. “DESyne BDS Plus with local anticoagulation delivery technology was designed to help mitigate the variable of drug compliance and to simplify the tradeoff decision of balancing the ischemic and bleeding risk. We are pleased to share the exciting findings from the first trial of DESyne BDS Plus as our team continues to innovate in the PCI space with our multiple platforms of disruptive technologies.”

The DESyne BDS Plus RCT includes 202 patients across 14 sites in Europe, New Zealand and Brazil. An imaging subset of 60 patients had angiographic and optical coherence tomography (OCT) assessment completed at six months. Data collection will continue through three years.

The data will be presented in the session “TCT Innovation V: Innovation in Coronary Disease Diagnosis and Therapies” on October 25th from 8-9:30 AM PDT in the Innovation & Clinical Science Theater, Hall B at the Moscone Center.

Elixir Medical is also hosting the scientific symposium, “Innovation for PCI: Improved outcomes require disruption” featuring a panel of speakers including Robert W. Yeh, M.D., Mirvat Alasnag, M.D, Ignacio Cruz-Gonzalez, M.D., Ph.D., Roxana Mehran, M.D. and Stefan Verheye, M.D., Ph.D.

The Elixir team will also exhibit at booth 115.

Full list of presentation details:

Innovation session: TCT Innovation V: Innovation in Coronary Disease Diagnosis and Therapies

Title: A Randomized Clinical Trial of a Novel Triple Drug Eluting Coronary Implant Eluting Two Anticoagulants and Sirolimus: Six-Month Clinical and Imaging Results of the DESyne BDS Plus Study

Presenter: Stefan Verheye, M.D., Ph.D.

Date: Wednesday, October 25, 2023

Time: 8:00 AM - 9:30 AM PDT

Location: Innovation & Clinical Science Theater, Hall B

Scientific symposium

Title: Innovation for PCI: Improved Outcomes Require Disruption

Presenters: Robert W. Yeh, M.D., Mirvat Alasnag, M.D., Ignacio Cruz-Gonzalez, M.D., Ph.D., Roxana Mehran, M.D. and Stefan Verheye, M.D., Ph.D.

Date: Tuesday, October 24, 2023

Time: 12:30 PM PDT

Location: Presentation Theater 3, Room 215, Level 2

Spotlight session: Coronary Spotlight 5: Disruptive Stent Technologies

Title: DynamX Coronary Bioadaptor Technology

Presenter: David Erlinge, M.D., Ph.D.

Date: Tuesday, October 24, 2023

Time: 3:30 PM - 4:55 PM PDT

Location: Coronary Spotlight Theater, Hall E, Exhibition Level

Spotlight session: Coronary Spotlight 5: Disruptive Stent Technologies

Title: DESyne BDS Plus Stent

Presenter: Stefan Verheye, M.D., Ph.D.

Date: Tuesday, October 24, 2023

Time: 3:30 PM - 4:55 PM PDT

Location: Coronary Spotlight Theater, Hall E, Exhibition Level

Session: Vulnerable Plaque Studies

Title: Plaque Stabilization and Regression: Another Significant Benefit of DynamX Bioadaptor

Presenter: Stefan Verheye, M.D., Ph.D.

Date: Wednesday, October 25, 2023

Time: 10:00 AM - 10:54 AM PDT

Location: Moderated Abstracts Station 8 – Emerging Clinical Science & Research Sessions, Hall C, Exhibition Level

Session: BVS Studies II

Title: 12-Month Clinical Outcomes of Patients Treated with the Novel DynamX Bioadaptor: DynamX Hong Kong Registry

Presenter: Wai Kin Chi, M.D.

Date: October 25, 2023

Time: 11:00 AM - 12:03 PM PDT

Location: Moderated Abstracts Station 6 – Emerging Clinical Science & Research, Hall C, Exhibition Level

Session: BVS Studies II

Title: Positive Adaptive Remodeling Effect of the DynamX Bioadaptor in BIOADAPTOR RCT

Presenter: Mark Webster, M.D.

Date: October 25, 2023

Time: 11:00 AM - 12:03 PM PDT

Location: Moderated Abstracts Station 6 – Emerging Clinical Science & Research, Hall C, Exhibition Level

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 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.

About 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 DESyne BDS Plus Triple Drug-Eluting Stent 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 60 patients had angiographic and optical coherence tomography (OCT) assessment completed in the first six months. Data collection will continue through five years.

About DESyne BDS Plus Stent

DESyne BDS Plus is the world’s first triple drug-eluting stent with local anticoagulation delivery technology using two anticoagulants (rivaroxaban and argatroban) and an antiproliferative mTOR inhibitor, sirolimus. The technology was designed to address challenges associated with percutaneous coronary intervention (PCI), including management of ischemic and bleeding risk.

About DynamX® Coronary Bioadaptor System

DynamX coronary bioadaptor is the first coronary implant technology designed to unlock the scaffold, uncage the vessel, and restore sustained normal vessel motion and function after 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 with remarkably low clinical event rates.

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