Elixir Medical Announces Commencement Of Infinity-Swedeheart Randomized Controlled Trial of DynamX Coronary Bioadaptor System

MILPITAS, Calif. – March 16, 2021 – Elixir Medical, a developer of innovative, drug-eluting cardiovascular devices, today announced commencement of the INFINITY-SWEDEHEART randomized controlled trial (RCT) of the DynamX™ Coronary Bioadaptor System, the first metallic coronary artery implant that adapts to vessel physiology.

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 DES. Over six 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 (a) maintain the ability for positive adaptive remodeling, (b) restore vessel function, and (c) allow for the vessel’s return toward baseline angulation.¹

The bioadaptor is designed to address the major adverse cardiac event (MACE) rate that occurs with drug-eluting stents each year without plateau.^2,3,4 The rigid design of a DES constrains, or “cages,” natural artery movement, restricting its natural ability to accommodate disease progression. This has been associated with MACE.⁵ Studies have shown adverse event rates associated with DES of 20 percent at five years² and 40 to 50 percent at 10 years.³ Published papers have demonstrated that a DES prevents positive adaptive remodeling,⁶ inhibits vessel compliance and dilation in response to the body’s changing blood flow needs,^7,8 and causes vessel straightening, which has been associated with increased MACE.⁹

“Drug-eluting stents 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,” said Professor Erlinge. “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.”

“Swedish quality registries, including SWEDEHEART, have been utilized by Uppsala Clinical research center (UCR) 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,” said Professor James. “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.”

The DynamX Bioadaptor has been shown to improve vessel function¹ in several ways. It enables the vessel to accommodate disease progression and achieve positive adaptive remodeling by increasing vessel area and maintaining lumen diameter, which preserves blood flow to the heart. DynamX restores vessel function and allows for normal vessel pulsatility and motion, enabling it to provide more blood flow in response to the body’s needs during physical activity. It also allows the vessel to return to baseline angulation, which may reduce adverse events.

“The INFINITY-SWEDEHEART RCT utilizing the respected SWEDEHEART registry database is an efficient approach to conducting an evidence-based trial, and provides important benefits. For the first time, we will be able to compare the performance of the physiologically-adaptive DynamX against an industry-leading DES in the overall study population and in subsets of patients. In addition, by leveraging the existing rigorous SWEDEHEART registry database, we will be able to conduct the trial and follow-up with high quality, efficiency and speed,” said Motasim Sirhan, Elixir Medical’s CEO.