INFINITY-SWEDEHEART RCT Commences for Elixir Medical’s DynamX Coronary Bioadaptor System

March 16, 2021—Elixir Medical announced commencement of the INFINITY-SWEDEHEART randomized controlled trial (RCT) of the company’s DynamX coronary bioadaptor system, a metallic coronary artery implant that adapts to vessel physiology.

The INFINITY-SWEDEHEART RCT is a prospective, multicenter, single-blind, randomized study. Investigators will enroll 2,400 patients at approximately 20 sites in Sweden who will be randomized 1:1 to treatment with the DynamX device or the Resolute Onyx drug-eluting stent (DES; Medtronic).

According to the company, the study design uses the rigorous SWEDEHEART registry database to support patient follow-up. The primary endpoint of the study is a device-oriented clinical endpoint of noninferiority of target lesion failure, a composite endpoint that includes cardiovascular death, target vessel myocardial infarction, and ischemia-driven target lesion revascularization at 1 year.

Powered secondary endpoints include superiority in the overall population and prespecified subgroups, including small vessel, long lesions, left anterior descending artery, chronic angina, and diabetes.

Professor David Erlinge, MD, of Lund University in Lund, Sweden, is the Principal Investigator of the INFINITY-SWEDEHEART RCT. Professor Stefan James, MD, from Uppsala University Hospital in Uppsala, Sweden, chairs the Executive Steering Committee for the trial.

“DESs have been very useful in opening blocked arteries, but the rigid stent structure cages the artery, impacting its ability to respond to disease progression and maintain blood flow lumen, as it would otherwise do naturally,” commented Professor Erlinge in Elixir Medical’s press release. “We are enthusiastic about studying the novel DynamX device, which is the first metallic device treating coronary artery disease that has been shown to restore pulsatility and positive adaptive remodeling of coronary arteries. The benefits of restored vessel function may provide greater benefit in patients with complex disease. The INFINITY-SWEDEHEART study includes these complex patients with both chronic coronary syndrome and acute coronary syndrome.”

Professor James added, “Swedish quality registries, including SWEDEHEART, have been utilized by Uppsala Clinical Research Center for a number of groundbreaking cardiovascular clinical trials, and it is appropriate that a unique device such as the DynamX device would be evaluated in a large number of patients using its infrastructure. We have found the device as easy to deliver as a stent but with the potential to reduce long-term DES-associated risks and improve upon patient outcomes over time.”

Elixir Medical stated that the DynamX bioadaptor is a metal implant with a drug-eluting bioresorbable polymer coating that supports the coronary artery during healing, with radial strength similar to a DES. Over 6 months, the polymer coating dissolves, uncaging the bioadaptor and freeing the artery to move with the natural expansion and contraction of the artery, unlike DES. This has been shown to maintain the ability for positive adaptive remodeling, restore vessel function, and allow for the vessel’s return toward baseline angulation.

The bioadaptor is designed to address the major adverse cardiac event rate that occurs with DES. The rigid design of a DES constrains (or “cages”) natural artery movement, restricting its natural ability to accommodate disease progression.

The DynamX coronary bioadaptor system is CE Mark approved. It is not available for sale in the United States.