Elixir Medical (Elixir), a developer of disruptive technologies to treat coronary artery disease (CAD), has released data from the INFINITY-SWEDEHEART randomized controlled trial (RCT), the largest RCT of the DynamX bioadaptor. This study compared the bioadaptor device to a current generation of drug-eluting stent (DES) in patients with both acute and chronic coronary syndrome, including those with complex vessel conditions such as long lesions, small vessels, and calcified lesions. The results showed that the bioadaptor met its primary safety goals, with significantly fewer device-related complications from 6 to 12 months compared to DES. Notably, in high-risk acute coronary syndrome patients, the bioadaptor demonstrated superior performance with an 83% lower target lesion failure rate, reinforcing its potential for better long-term outcomes.

“Data gleaned from the INFINITY-SWEDEHEART RCT have important implications for the future of the treatment of CAD, said David Erlinge, M.D., Ph.D., study principal investigator and head of the Cardiology Department at Lund University, Lund, Sweden. “Historically, patients with acute coronary syndrome (ACS) are at a higher risk for adverse events after percutaneous coronary intervention (PCI) in part because of higher rates of comorbidities, reduced heart function, and more frail patient condition.”

He added, “Analysis of this critical population was key to understanding the effects of the DynamX bioadaptor’s unique mechanism of action on achieving excellent safety and effectiveness after PCI. With sustained reduction and plateauing of TLF after six months as compared to stents, the data further validates the substantial clinical benefit of the DynamX bioadaptor and its potential to impact the treatment and long-term success in high-risk patient populations.”

CAD is a condition where plaque build-up narrows the coronary arteries and reduces blood flow to the heart, leading to ACS, where the plaque ruptures or a blood clot forms, causing a sudden and critical reduction in blood flow to the heart.

Percutaneous coronary intervention (PCI) describes the procedure that treats CAD by opening up clogged arteries and restoring blood flow, with drug-eluting stents (DES) having become the global standard treatment for CAD since their introduction in the early 2000s.

Target lesion failure (TLF) is an outcome measure used in clinical trials to assess if coronary interventions have been successful, particularly after stent implantation. It refers to any significant issue at the specific site or ‘target lesion’ that was treated, including:

1. Target lesion revascularization: A repeat procedure specifically at the site within the stent or a few millimeters surrounding it, to treat a new occlusion of the treated lesion
2. Myocardial infarction: Any heart attack related to the target lesion.
3. Cardiac death: Death attributed to cardiovascular causes and related to the target lesion. 

Rise of cardiovascular disease and need for percutaneous coronary intervention (PCI) procedures in Singapore

At the Singapore Cardiac Society’s 34th Annual Scientific Meeting, in March 2023, Health Minister, Mr. Ong Ye Kung said, “Since 2010, cardiovascular disease (CVD) accounted for about 33% of all deaths in Singapore. It is high, but fortunately steady and not worsening. However, the signs are worrying, as the prevalence of obesity, hypertension and hyperlipidemia is rising in Singapore”.

His statement is supported by recent data published in 2021, which showed acute myocardial infarction (AMI) and stroke being the leading causes of death.  AMI occurs when blood flow is diminished due to the obstruction of a coronary artery, causing low oxygen supply to the cells in the heart, leading to cell death and loss of heart tissue.

The rise of CVD in Singapore is driving the rise for the need for PCI. In 2022, the National Heart Centre Singapore (NHCS) alone reported performing 2,196 coronary angioplasty and stenting procedures, and also predicts that Singapore will see a growing demand for PCI procedures in the near future.

“Interest in the DynamX bioadaptor technology has grown significantly in the medical community, especially with robust data and live demonstrations showing its efficacy in complex cases. Operators value its deliverability and its ability to preserve pulsatility, making it an attractive option in cardiology,” said Dr. Lim Ing Haan, Consultant Interventional Cardiologist, Mount Elizabeth Medical Centre, Singapore.

INFINITY-SWEDEHEART Data

The 12-month INFINITY-SWEDEHEART RCT data were published as a peer-reviewed article in The Lancet entitled, “Bioadaptor implant versus contemporary drug-eluting stent in percutaneous coronary interventions – 12 months primary outcomes of the INFINITY-SWEDEHEART randomized non-inferiority trial” [8]. It included an analysis of patients with ACS, small vessel lesions, and lesions within the left anterior descending artery.

In a landmark analysis, after six months, the data demonstrated that in patients with ACS, the DynamX bioadaptor had significantly fewer incidents of target lesion failure (TLF) compared to the contemporary the drug-eluting stent, i.e., 0.3% TLF rate for the DynamX bioadaptor versus 1.8% for the drug eluting stent (p<0.018). This translated into an 83% reduction and significant benefit for DynamX bioadaptor compared to the stent it was being tested against.

The National Heart Centre Singapore (NHCS) has treated approximately 100 patients with the DynamX bioadaptor, according to a press release issued in conjunction with Singapore LIVE (SingLIVE), a medical conference in cardiac interventions which concluded on 18 January 2025.

 The DynamX bioadaptor represents an innovative new solution in coronary interventions. As we continue to gather data and experience, we are increasingly optimistic about the device's role in advancing the standard of care for patients with coronary artery disease," explained Associate Professor Lim Soo Teik, Senior Consultant, Department of Cardiology, and Advisor, Cardiac Catheterisation Laboratory, NHCS . Associate Professor Lim also implanted the device into a patient as part of a demonstration at SingLIVE.

Additionally, patients with lesions in the left anterior descending (LAD) artery demonstrated 73% reduction in TLF — 0.2% compared to. 2.2% — after six months with the DynamX bioadaptor compared to treatment with the drug-eluting stent. There were also no TLF events in patients with small vessels of less than or equal to 2.75mm, in the DynamX bioadaptor arm compared to 1.8% TLF with the contemporary drug-eluting stent after six months.

“Despite decades of innovation, DES and bioresorbable scaffolds continue to show a 2% to 3% non-plateauing adverse event rate increase per year*, impacting 40% to 50% of patients within 10 years. The team at Elixir believed it was essential to restore vessel function to elevate CAD treatment effectiveness and worked tirelessly to develop the DynamX bioadaptor to address this major challenge,” said Motasim Sirhan, CEO and founder of Elixir Medical.

“Three key aspects stood out to me with regards to the bioadaptor technology, and they are safety, lower rates of TLF, and plaque regression. The bioadaptor demonstrated safety comparable to traditional DES and showed reduced TLF rates at two years. What was most surprising was that the bioadaptor demonstrated regression of plaque volume behind the stent, a phenomenon not seen with traditional stents,” added Dr Lim.

 *A non-plateauing adverse event rate increase per year means that the chances of a target lesion failure continue to increase every year by 2 to 3%.

Mechanism of the DynamX^® Coronary Bioadaptor System (the DynamX bioadaptor)

The earlier BIOADAPTOR RCT [10] demonstrated:

1. Excellent Performance in High-Risk Lesions: The DynamX bioadaptor demonstrated a 78% reduction in TLF in high-risk lesions, such as the left anterior descending artery (LAD) (1.9% vs. 8.7%, p=0.028), with lower event rates for small vessels and long lesions (0% vs. 3.6% and 0% vs. 2.3%, respectively).
2. Restoration of Natural Artery Function: The DynamX bioadaptor is the first technology designed to restore natural artery function through hemodynamic modulation, potentially improving long-term outcomes for coronary artery disease patients.
3. Potential New Standard of Care: The DynamX bioadaptor's unique design and clinical results have the potential to establish a new standard of care in the treatment of coronary artery disease.

Unlike traditional PCI technologies, the DynamX bioadaptor leverages a unique mechanism of action that is designed to restore vessel motion and function by unlocking its helical strands after six months to provide adaptive, dynamic support to help the vessel better respond to the body’s physiological demands.

The DynamX bioadaptor has been used to treat thousands of patients to date and has growing physician experience in complex PCI cases, including primary PCI, chronic total occlusions, bifurcations, and calcified lesions.