Elixir Medical (Milpitas, Calif., and Tokyo) announced that its DynamX® Sirolimus-Eluting Coronary Bioadaptor System for the treatment of coronary artery disease has received medical device approval (marketing approval) from Japan’s Minister of Health, Labour and Welfare.

The DynamX Sirolimus-Eluting Coronary Bioadaptor System (DynamX®) is the first and only coronary implant approved in Japan specifically designed to restore vascular function through a process known as “hemodynamic modulation” following percutaneous coronary intervention (PCI). Compared with drug-eluting stents (DES), DynamX® has demonstrated improved patient survival and reduced repeat interventions in clinical data.

The approval establishes bioadaptors as a new medical device category in Japan and highlights the leadership of Japan’s Ministry of Health, Labour and Welfare and the Pharmaceuticals and Medical Devices Agency (PMDA) in incorporating the latest clinical innovations into cardiovascular care.

DynamX® aims to establish a new treatment approach for PCI by restoring vascular function

Dr. Shigeru Saito, Principal Investigator of the BIOADAPTOR RCT and Director of the Heart Center at Shonan Kamakura General Hospital in Kamakura, Kanagawa, said:

“The randomised trial demonstrated restoration of hemodynamic function and significant improvements in clinical outcomes. Based on these results, I am confident that DynamX® will become a new standard of care for the treatment of coronary artery disease.”

Professor Stefan Verheye, MD, interventional cardiologist at ZNA Cardiovascular Center in Antwerp, Belgium, and a leading researcher in bioadaptor technology, said:

“The coronary arteries have two primary functions. One is to carry blood flow, while the other is to adapt to changes in cardiac load through pulsatility, elastic expansion and contraction, and compliance, thereby maintaining healthy vessel-wall function. These properties are collectively referred to as hemodynamic modulation. When atherosclerotic plaque thickens the vessel wall and progresses to severe obstruction, this important function is impaired.”

“For decades, the treatment of coronary artery disease has focused on opening narrowed vessels with stents or balloons to restore blood flow, without addressing the artery’s natural function of hemodynamic modulation. This has contributed to challenges associated with increasing adverse events over time. The DynamX bioadaptor is the only CAD treatment designed to achieve both restoration of blood flow through lesion opening and restoration of the artery’s hemodynamic function. Clinical studies have demonstrated significant improvements in outcomes compared with conventional treatments.”

The approval of DynamX® is supported by clinical evidence from two randomised controlled trials, BIOADAPTOR RCT and INFINITY-SWEDEHEART, which compared the bioadaptor with the standard-of-care drug-eluting stent Resolute Onyx.

In the BIOADAPTOR RCT, DynamX® demonstrated restoration of pulsatility and compliance, as well as increased blood flow, providing the first evidence that the technology can restore both blood flow and arterial function.

Four-year follow-up results from the BIOADAPTOR RCT, presented at EuroPCR 2026, showed a significant reduction in target lesion failure (TLF) compared with DES, at 2.8% versus 7.8% (p=0.02), representing a 66% reduction. DynamX® also demonstrated a significant improvement in cardiovascular mortality, with cardiovascular death rates of 0.5% versus 3.7% (p=0.02), representing an 88% improvement, alongside reductions in new myocardial infarctions and repeat revascularisation procedures.

In addition, the large European post-market clinical study INFINITY-SWEDEHEART, involving 2,400 patients with complex lesions and acute coronary syndrome, demonstrated a consistent 48% improvement in clinical outcomes compared with drug-eluting stents after the bioadaptor’s mechanism for restoring hemodynamic function became active six months after implantation.

The approval of DynamX® as a new medical device category for coronary artery disease treatment in Japan, together with its designation as a Breakthrough Device by the US FDA, reflects growing recognition of the bioadaptor’s unique mechanism of action, demonstrated therapeutic benefits and clinical improvements in PCI outcomes compared with existing standards of care.

Approval marks an important milestone for Japanese patients and physicians

Motasim Sirhan, CEO of Elixir Medical, said:

“We developed DynamX® to overcome the limitations of conventional metallic drug-eluting stents and ‘leave nothing behind’ approaches. The device continuously provides structural and dynamic support at the lesion site while freeing the vessel from the constraints of a permanent implant, enabling the artery to recover its natural function following PCI. This approval is excellent news for patients.”

Following reimbursement approval, Elixir Medical plans to work with the Japanese Association of Cardiovascular Intervention and Therapeutics (CVIT) and leading cardiovascular institutions across Japan to make this new treatment option available to patients with coronary artery disease.