Elixir MedicalAnnounced at the ESC2024 conference aboutDynamXClinical research (INFINITY-SWEDEHEART) showsDynamXSuperior toTraditional drug-eluting stents significantly reduce adverse events post-surgery (more pronounced over time).
INFINITY-SWEDEHEART is a large-scale, prospective, multicenter, single-blind, randomized controlled (1:1) clinical trial (RCT), enrolling a total of 2,400 patients with coronary heart disease. The experimental group is DynamX, and the control group is the industry benchmark product Resolute Onyx DES (Medtronic).
Specific Research Data
One year post-operation, DynamX and Resolute Onyx DESTarget Lesion Failure (TLF)2.35% and 2.77%, respectively (p<0.001). The lower TLF of DynamX was due to the lower number of adverse events in the DynamX composite endpoint components.
Target Vessel Myocardial Infarction (TV-MI) (Experimental group: 1.27%, Control group: 1.52%)Ischemia-Driven Target Lesion Revascularization (ID-TLR)Experimental Group:1.27%， Control Group:2.11%）Cardiovascular death (Experimental Group：0.59% ，Control Group:0.50%）- Compared with the control group, the Target Vessel Failure (TVF) at 12 months was also lower in the experimental group, which were 3.03% and 3.52%, respectively.
- 6 Months Post-OperationDynamXThePolymer Coating Dissolution，Stent structure release. Research data six months after release showsDynamXSignificant Clinical Advantages:
The TLF in the experimental group was significantly reduced, by approximately 85%.（Experimental Group：0.2% ， Control Group:1.3%，p=0.003）Experimental GroupTVF alsoSignificantly reduced,Reduced by approximately 67%（Experimental Group：0.6% ， Control Group:1.8%，p=0.008）PI Evaluation
"DynamX represents a significant clinical advancement in the treatment of coronary artery disease, with a unique mechanism of action within six months post-PCI. Millions of patients globally undergo PCI each year, and while stent implantation is a very safe procedure, it is associated with an annual rate of adverse events post-surgery. The sustained reduction and stabilization of these recurring adverse clinical events will bring substantial long-term benefits to patients throughout their lives."
---David Erlinge Lund University"Our trial results strongly support the clinical impact of DynamX in the treatment of coronary artery disease, with the potential to significantly reduce the incidence of adverse events after PCI procedures. It has been proven that DynamX can achieve a low rate of adverse events through its unique design and mechanism of action in restoring hemodynamic regulation in diseased arteries."
--- Stefan James Uppsala University
Executive Evaluation
"The results of the INFINITY-SWEDEHEART clinical study validated our previous findings shown in the BIOADAPTOR RCT, as well as in several mechanistic and investigator-initiated studies—low adverse event rates post-DynamX procedure—within a broader and clinically more complex patient population. We are very excited about the 6 to 12-month post-procedure analysis data, which shows a statistically significant reduction in TLF and TVF for DynamX compared to DES. As an innovation-driven company, these data further validate DynamX’s unique mechanism of action and its advantages in treating coronary artery disease, thereby raising the standard of care for our patients."--- Motasim Sirhan CEO of Elixir Medical
DynamXIs the first coronary stent designed to adapt to vascular physiology.DynamXIt is a coronary stent with a drug-eluting, bioabsorbable polymer coating that supports the coronary arteries during the healing process, providing radial strength comparable to traditional stents.Drug-Eluting StentSimilar. AndTraditionalDrug-ElutingDifferent, after six months, the polymer coating dissolves,The stent structure can be loosened but maintains longitudinal continuity., allowing it to move freely with the natural expansion and contraction of the artery. This helps maintain active adaptive remodeling capacity, restore vascular function, and allow the vessel to return to its baseline angle.DynamXThe stent is71um thickGulow alloy,The coating is biodegradable novomos.。
Comparison between DynamX and DES
Traditional DES can open narrowed blood vessels, but may also cause the lesion area to become occluded.This maintains the area of the blood vessel and stent, but as the disease continues to progress, the lumen area will decrease.The adapter can also open narrow blood vessels while self-regulating remodeling, pulsatility, and the natural curvature and elasticity of arteries, potentially reducing adverse event reactions in the future. Normal coronary arteries expand in response to atherosclerosis or disease progression, a process known as positive adaptive remodeling, which slows disease progression and helps maintain blood flow and oxygen supply to the myocardium.It maintains the lumen area and good blood flow as the artery at the lesion site expands.
Elixir Medical A medical device company located in California, USA, that develops next-generation platforms for treating coronary artery and peripheral artery diseases, aiming to restore adaptive remodeling and pulsatile motion capabilities of blood vessels. Its mission is to transform care for patients with heart and vascular diseases through innovation.
