The first head-to-head randomized clinical trial (RCT) of DynamX Bioadaptor compared to Resolute Onyx DES shows statistically significant effectiveness in restoring vessel pulsatility, achieving significantly lower late lumen loss (LLL) and percent diameter stenosis. The primary endpoint of Target Lesion Failure (TLF) was met with an exceptionally low event rate for DynamX, and across all safety and efficacy components of TLF. Novel finding of in-device plaque stabilization and regression with DynamX compared to an increase with DES.

At a late-breaking clinical session during the EuroPCR 2023 conference in Paris, Elixir  Medical - a developer of breakthrough cardiovascular technologies, announced the result of the large international randomized BIOADAPTOR RCT trial of the company’s DynamX® Coronary Drug-Eluting Bioadaptor compared to Resolute OnyxTM Drug-Eluting Stent, for the first time seen in a coronary revascularization implant, the bioadaptor scaffold demonstrated normal pulsatility in the device treated segment, confirming the therapy safely restores artery movement and function with excellent effectiveness at 12 months.

Coronary artery disease (CAD) is the most prevalent type of heart disease, and the third most common cause of mortality worldwide.  Every year, approximately 200,000 patients in Vietnam die from cardiovascular diseases. Among cardiovascular disorders, CAD is amongst the leading causes of death or disability. CAD develops when fatty materials build up in the artery, causing it to narrow, making it difficult for oxygen-rich blood to reach the heart. To re-establish blood flow, physicians often use a technique called revascularization, which opens up the blocked artery. This may require implanting a stent, where a structure called a scaffold is locked in place to keep the artery open.

DynamX Bioadaptor is a new type of coronary implant designed to unlock the scaffold, uncage the vessel, to return normal vessel motion and function after percutaneous coronary intervention (PCI), with continued dynamic support of the atherosclerotic vessel to reduce long-term adverse events. In the study, the bioadaptor demonstrated superior effectiveness of its unique mechanism of action across secondary intravascular imaging endpoints, achieving restoration of the vessel motion and function compared to persistent constraint with DES.

The BIOADAPTOR RCT trial has been conducted across 445 patients in Japan and Europe across 12 months and shown ground-breaking  results:

Clinical Safety and Efficacy Results: 1.8 % Primary endpoint - Target lesion failure at 12 months vs. 2.8% for DES (p < 0.001). Device Effectiveness and Vessel Function Results: 16% Increase in blood flow with every heartbeat, as pulsatility returns.Novel Finding of Plaque Stabilization and Regression: -9% Plaque volume regression in lipid rich lesions vs. +10% for DES (p = 0.008).

Principal investigator Shigeru Saito, M.D and director of the Division of Cardiology and Catheterization Laboratory at Shonan Kamakura General Hospital in Kamakura, Japan. “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. These findings establish that the bioadaptor addresses the shortcomings of DES and bioresorbable scaffolds, and collectively point to a technology effectiveness standard not seen before. The finding of plaque changes is very exciting, pointing to a new effect and potential benefit of restoring vessel function”.

“With this new stent - DynamX bioadaptor can change the way of treatment because of the positive results from new stages after intervention to the average period and even the long-term results demonstrated the return of vascular dynamics, providing very good long-term quality of life for patients. This is a groundbreaking finding because 30 years ago coronary artery disease was incurable but even with the answer of drug-eluting stents in recent years, the long-term results of 5-10 years off drug-eluting stents still have its own problems and compromises. The new bioadaptor stent offers very encouraging results with confidence, so that interventional cardiologists use this new stent for their patients, the results are very positive now and in the long run.``Prof. Doctor Thach Nguyen, the first Vietnamese-American committee member of the American Heart Association and Society for Cardiovascular Angiography and Intervention comments. “In the near future, treating coronary artery disease with DynamX bioadaptor stent is a feasible solution that brings good results for patients everywhere from the US, Europe, China, and Vietnam.” Prof. Dr Thach Nguyen added.

Prof. Doctor Pham Manh Hung - Vice President of Vietnam Cardiology Association, Head of National Cardiology Hospital

Prof. Doctor Pham Manh Hung - Vice President of Vietnam Cardiology Association, Head of National Cardiology Hospital shared: “Through research, I learned that this is a very special system, designed to overcome the disadvantages of the other traditional drug-eluting stents, thanks to the drug-eluting joints after a period of time being inserted into the patient's veins, the drug-eluting polymer layer disappears, releasing the joints,releasing the vessels to pulsate more freely, resulting in the return of normal blood vessels movement, unlike the old stent, there is still a the metal framework that exists there prevents the blood vessels from having normal peristalsis, resulting in the patient still suffers from the remaining symptomatic, the second  problem is not reducing the burden of plaque regression because we know that the stents of the old generation are not peristaltic, can't move, so the atheroma will progress very quickly, a very fast developing threat. But with this innovative stent, we return the natural movement to the vessel along with the medications, the atherogenic effect the plaque grows more slowly and even recedes. These are the great benefits of the bioadaptor system to my knowledge. I am expecting more studies on a larger number of patients to soon demonstrate the superiority of this technology compared to drug-eluting stents.”

“For many years, Elixir persevered to develop breakthrough technologies to elevate PCI treatment effectiveness for patients worldwide. Development of the DynamX Bioadaptor - the first coronary scaffold technology designed to unlock, uncage the vessel, and restore and sustain normal vessel motion and function - has been a multi-year journey, and today we are humbled to report results that elevate PCI treatment effectiveness,” said Motasim Sirhan, CEO of Elixir Medical. “We are committed to elevating the standard of care for patients with heart disease. It is not only the patients with heart attack or patient in PCI as we know it today, but we aspire and we have implant today technology to address vulnerable plague patients and patients with chronic angina symptoms”.