Elixir’s Dynamx Bioadaptor System Studied in INFINITY-SWEDEHEART RCT

July 13, 2023—Elixir Medical announced the completion of enrollment in the INFINITY-SWEDEHEART randomized clinical trial (RCT) evaluating the company’s next-generation Dynamx coronary bioadaptor system.

The Dynamx system is a sirolimus-eluting metallic coronary artery implant that is engineered to adapt to vessel physiology. It has received CE Mark approval. It is not available for sale in the United States.

Elixir Medical stated that the prospective, multicenter, single-blind, INFINITY-SWEDEHEART RCT will evaluate the safety and efficacy of the Dynamx device compared with the Resolute Onyx zotarolimus drug-eluting stent (DES; Medtronic) in the treatment of patients with ischemic heart disease. The trial will be conducted in a broader patient population than the previous BIOADAPTOR RCT of the Dynamx.

According to the company, the INFINITY-SWEDEHEART trial will enroll 2,400 patients, randomized 1:1, from 14 sites across Sweden. The primary device-oriented clinical endpoint is target lesion failure (TLF; a composite of cardiovascular death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization. Secondary endpoints include testing for superiority in the reduction of TLF and angina pectoris with the bioadaptor versus the DES in all patients and in prespecified subgroups.

INFINITY-SWEDEHEART is the fourth trial of the DynamX bioadaptor’s clinical evidence program, which consists of nine company-sponsored and investigator-initiated studies enrolling more than 9,000 patients. The trial is part of the ongoing SWEDEHEART registry program, a national collaborative research program in Sweden that was launched in 2009 to support the evidence-based development of therapies for coronary heart disease.

The trial will build on the body of evidence demonstrated in the BIOADAPTOR RCT, which is composed of 445 patients, and it compared the DynamX bioadaptor to the Resolute Onyx.

In May, Elixir Medical announced the presentation of results from the BIOADAPTOR RCT at the EuroPCR conference held May 16-19 in Paris, France. The trial met its primary endpoint of TLF noninferiority at 12 months.

The principal investigator of the INFINITY-SWEDEHEART RCT is Professor David Erlinge, MD, of Lund University in Lund, Sweden. Professor Stefan James, MD, of Uppsala University Hospital in Uppsala, Sweden, is chairman of the SWEDEHEART steering committee.

“For more than 20 years, generations of drug-eluting stents have offered no hard clinical benefits beyond the first year for the treatment of ischemic heart disease and no advancements have been made to address the annual nonplateauing adverse events,” commented Prof. Erlinge in the company’s press release.

Prof. James added, “This trial is conducted through a robust national SWEDEHEART registry and includes patients we typically see in our practices, with both chronic and acute coronary syndromes, and will provide important data to potentially change the future of percutaneous coronary intervention treatment.”