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Elixir Medical, a California-based company, may have struck gold in the realm of vascular restoration with their innovative device, the DynamX Coronary Drug-Eluting Bioadaptor. The groundbreaking data was unveiled at the 2023 EuroPCR event held in France and revealed the device's ability to restore vessel function after a year of its application.
The DynamX Bioadaptor: A New Approach to Vascular Restoration
The DynamX Bioadaptor is a one-of-a-kind coronary implant technology that has been designed to address the limitations associated with traditional drug-eluting stents (DES) and bioresorbable scaffolds. The scaffold of the device is formed from three metallic helical strands which are joined circumferentially by a thin bioresorbable polymer coating. This design provides radial strength during implantation. However, the real magic happens after six months when the polymer is resorbed. This process unlocks the scaffold, unleashing the vessel and restoring its normal motion and function.
"The DynamX Bioadaptor is the first coronary implant technology designed to unlock the scaffold, uncage the vessel, and restore and sustain normal vessel motion and function after percutaneous coronary intervention (PCI) with continued dynamic support of the diseased vessel." - Elixir Medical
BIOADAPTOR RCT Study: Superior Efficacy of the DynamX Bioadaptor
In the BIOADAPTOR RCT study, the DynamX Bioadaptor was pitted against Medtronic's Resolute Onyx DES. The device not only met its primary endpoint of target lesion failure (TLF) non-inferiority at 12 months but also outshone the DES in terms of effectiveness across secondary intravascular imaging endpoints.
The DynamX Bioadaptor achieved a remarkably low TLF rate of 1.8% compared to the 2.8% for Resolute Onyx DES.
results = {
'DynamX Bioadaptor': '1.8%',
'Resolute Onyx DES': '2.8%',
}
print(f"DynamX Bioadaptor TLF rate: {results['DynamX Bioadaptor']}")
print(f"Resolute Onyx DES TLF rate: {results['Resolute Onyx DES']}")
Clinical Outcomes and Restoration of Vessel Function
Dr. Shigeru Saito, the principal investigator and director of the division of cardiology and catheterization laboratory at Shonan Kamakura General Hospital in Kamakura, Japan, praised the innovative technology.
"The DynamX Bioadaptor exceeded our expectations against a good DES in clinical outcomes, and for the first time ever demonstrated restoration of vessel pulsatility, motion and function by uncaging the vessel." - Dr. Shigeru Saito
According to the trial, there were no cardiac deaths in the DynamX arm, and very low rates of target vessel myocardial infarction, and target lesion revascularization in both arms.
The BIOADAPTOR RCT Study: Design and Patient Demographics
The BIOADAPTOR RCT is an international, single-blinded, randomized control trial that compared a sirolimus-eluting Bioadaptor with a contemporary zotarolimus-eluting stent in 445 patients.
The trial was designed to document standard stent effectiveness benchmarks.
The trial aimed to determine the new effectiveness benchmarks of vessel motion and function.
Data collection will continue through five years.
The Unique Properties of the Bioadaptor
The Bioadaptor is a unique technology that is a metallic-based frame composed of three helical strands temporarily joined circumferentially. When the thin polymer coating is resorbed at six months, it allows the implant to unlock and the vessel to restore pulsatility, motion and function.
An Exciting Future for Vascular Restoration
Vascular device companies have long recognized the need to "uncage" the vessel to improve long-term outcomes. However, designing a device to successfully do so has been easier said than done. Elixir's DynamX Bioadaptor might just be the game-changer the field has been waiting for.
Elixir's Clinical Evidence Program
The BIOADAPTOR RCT is the third trial of Elixir's DynamX Bioadaptor clinical evidence program. The program consists of nine company-sponsored and investigator-initiated studies involving more than 9,000 patients.
Commercial and Market Development Activities
With a CE mark under its belt, Elixir is beginning commercial and market development activities in Asia, parts of Europe, and in the Middle East. The company also expects to file for Japanese approval based on this new data sometime this year.
A New Hope for Patients with Vulnerable Plaque
Elixir's CEO, Motasim Sirhan, expressed optimism about the potential of the DynamX Bioadaptor to address the needs of patients who have vulnerable plaque, a condition not necessarily responsive to statins due to the vessel becoming dysfunctional over time.
"The dynamics could be potentially uniquely suitable to address that large patient populations by being able to restore that vessel functionality and allowing the vessel to respond to systemic drugs like statins in a very synergistic manner." - Motasim Sirhan
The DynamX Bioadaptor thus represents an exciting leap forward in vascular restoration technology, offering hope for improved patient outcomes and transforming the standard of care in PCI.
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