Source: Heart Future; Editor: Felicia
Reprint Requirements: If the source of the article is indicated at the beginning of the text, it can be reprinted directly.Recently, Elixir Medical Corporation, which focuses on treating coronary artery and peripheral artery diseases,Elixir MedicalAt the European Society of Cardiology (ESC) Congress 2024 (ESC2024) held in London in 2024, a study on itsDynamX® Coronary Bioadaptor SystemThe clinical study (INFINITY-SWEDEHEART), a randomized controlled trial (RCT) that comparedDynamX® Coronary Bioadaptor SystemAndMedtronic Resolute Onyx™ Drug-Eluting Stent (DES)Clinical outcomes.
The study shows,DynamX® Outperforms Resolute Onyx™,Target Lesion Failure (TLF) was 2.35% and 2.77%, respectively (p<0.001).，Significantly Reduce Postoperative Adverse Events。
In June 2024, the DynamX® Coronary Bioadaptor System received U.S.FDA Breakthrough Device Designation，Used forTreatment of Symptomatic Ischemic Heart Disease. The implant is designed toImprove coronary artery lumen diameter, restore hemodynamic regulation, and reduce plaque progression.。Its unique design includes three stages.: Establish the maximum flow lumen, unlock the helical chain to allow for vascular growth, and provide adaptive dynamic support to restore vascular vitality and hemodynamic regulation.
To date, the use of drug-eluting stents for interventional treatment of coronary artery disease has been able to establish blood flow through angiography. However, although traditional drug-eluting stents have good safety and performance,But while traditional stent implantation avoids elastic recoil, it also affects the adaptive remodeling, rotation, and angulation of coronary vessels.。Adverse events related to stents increase steadily at a rate of 2%-3% per year after the first year, reaching 20% after 5 years and 50% after 10 years.%。For more than 2 years,The use of stents is the main reason for the increase in the annual rate of non-platform-related events.. However, relevant data on the use of bioresorbable scaffold technology shows,Even after stent reabsorption, non-platform event rates will still occur., there are still limitations such as excessive stent thickness and poor performance in the acute phase. Therefore, a more innovative approach is needed to restore vascular vitality.DynamX™ Sirolimus-Eluting Bioadaptor isThe First ClauseCoronary Stents Designed to Adapt to Vascular Physiology，Its design balances acute-phase clinical performance with bioresorbable characteristics., is expected to solve the aforementioned shortcomings of current PCI devices and has good application potential.
INFINITY-SWEDEHEART trial is a prospective, multicenter, single-blind, randomized controlled (1:1) clinical trial,Comparison of the Safety and Efficacy of the DynamX Sirolimus-Eluting Bioadaptor and the Resolute Onyx Zotarolimus-Eluting Stent (DES) in the Treatment of Patients with Ischemic Heart Disease。The study enrolled 2,400 patients aged 18-85 with chronic coronary syndrome (CCS) or acute coronary syndrome (ACS) who required stent implantation.DynamX Bioadaptor versus Resolute Onyx DES: TLF at 12 months were2.35% And2.77%，Met non-inferiority (p<0.001)The lower TLF of the DynamX Bioadaptor is due to its performance across the components of the composite endpoint.Fewer adverse events：- Target Vessel Myocardial Infarction (TV-MI) (1.27% VS 1.52%）
- Ischemia-Driven Target Lesion Revascularization (ID-TLR)1.27% VS 2.11%）
- Cardiovascular death (0.59% VS 0.50%）
- The 12-month target vessel failure (TVF) was also lower, with DynamX at3.03%, DES is 3.52%.
The polymer coating of DynamX dissolves and the stent structure loosens 6 months after surgery.Six-month post-procedure data demonstrates significant clinical advantages of the DynamX:
TLF in the DynamX group was significantly reduced by approximately 85%.(Experimental group: 0.2%, Control group: 1.3%, p=0.003);The TVF in the DynamX group was also significantly reduced, by approximately 67%.(Experimental group: 0.6%, Control group: 1.8%, p=0.008).
Chairman of the Study, Professor of Cardiology at Uppsala University, SwedenStefan James Dr. stated:"Our trial results strongly support the clinical impact of bioadaptors in the treatment of coronary artery disease in daily clinical practice."Significantly reduce the risk of recurrent adverse events in patients after percutaneous coronary interventionIt has been proven that the bioadaptor can achieve this through its unique design and mechanism of action, as well as by restoring hemodynamic regulation in diseased arteries."# DynamX Bioadaptor System
DynamX Bioadaptor isThe FirstThroughRestore vascular pulsatility, compliance, adaptive blood flow, and provide plaque stabilization and regression, proving that it can restore the hemodynamic regulation of coronary arteries.It is a coronary stent made of bioabsorbable polymer with a drug-eluting coating, providing support to the coronary arteries during the healing process.Radial strength similar to traditional drug-eluting stents. Unlike traditional drug-eluting,After six months, the polymer coating dissolves, allowing the stent structure to loosen but maintaining longitudinal continuity., allowing it to move freely with the natural expansion and contraction of the artery; thereby maintaining active adaptive remodeling capability,Restore vascular function and allow vessels to return to baseline angle。With this unique mechanism of action,DynamX Addressed the shortcomings of drug-eluting stents and bioresorbable scaffolds，Significantly reduce the incidence of clinical adverse events and stabilize after 6 months.. This was demonstrated in two randomized controlled trialsBIOADAPTOR-RCT (N=445) and INFINITY-SWEDEHEART (N=2400) in ChinaIt has been proven.[In May 2024, EuroPCR 2024 announced the latest two-year BIOADAPTOR RCT data, which showed that at the 24-month follow-up,The TLF incidence rate in the DynamX group compared to the Resolute Onyx group(2.3% vs. 5.5%, P=0.093) decreased by 59%, and there is a trend that the gap increases over time.】▲ Comparison of DynamX and DESDynamX BioadaptorHas a novel mechanism of action, throughThree Different PhasesAdapt in the body to restore a more normal vascular biological function:
Locking Phase: BioadapterEstablish a maximum flow cavity to restore blood flow。
Unlock/Separation Phase：Unique Function of Bioadapter. After six months, the helical stent unlocks and separates, allowing the vessel to undergo adaptive remodeling to maintain the established blood flow lumen.
Adaptive Dynamic Support Phase: Three independent helical stents continue to provide necessary support. BioadapterRestoration of Vascular Hemodynamic Regulation by Re-establishing Pulsatility, Compliance, and Adaptive Blood Flow。
▲ DynamX Bioadaptor – Helical Stent Unlocking and Separation
CEO of Elixir MedicalMotasim Sirhan Representation:"The data from the INFINITY-SWEDEHEART trial validated our previously demonstrated results from the BIOADAPTOR RCT and several mechanistic studies—within a broader and clinically more complex patient population."Six Months Post Bioadaptor Unlocking, Low and Stable Adverse Event Rate。We are very excited about the landmark analysis data six months later, which showCompared with drug-eluting stents, the DynamX Bioadaptor in TLF and TVFWith Significant Advantages。"As an innovation-driven company, these data further validate the unique mechanism of action of the bioadaptor and its advantages in the treatment of coronary artery disease, raising the standard of care for patients."
Elixir Medical Corporation is a medical device company located in California, USA.Developing the Next-Generation Platform for Treating Coronary and Peripheral Artery Diseases, aiming to restore vascular adaptive remodeling andPulsating exercise capacity. The company's mission is to transform the care of patients with heart and vascular diseases through innovation.
