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June 25, 2020

Twelve-Month Data Presented for Elixir Medical’s DynamX Bioadaptor System

June 25, 2020—Elixir Medical announced the presentation of 12-month data for the DynamX coronary bioadaptor system online as part of the Late-Breaking Trials session at the online PCR e-Course. The presentation by Stefan Verheye, MD, is available on-demand at PCR Online.

According to the company, the DynamX bioadaptor is a metallic drug-eluting coronary artery device designed to open and support the artery during healing, while accommodating the vessel’s ability to grow in response to disease progression. The device has CE Mark approval, but it is not available for sale in the United States.

The multicenter, single-arm, mechanistic clinical study enrolled 50 patients treated at six centers in Europe to evaluate the safety and performance of the DynamX bioadaptor in de novo native coronary arteries. Primary endpoints included target lesion failure and quantitative coronary angiography (QCA), intravascular ultrasound (IVUS), and optical coherence tomography (OCT) measures.

Elixir Medical reported that that the device demonstrated the following at 12 months:

  • No target vessel revascularization
  • No device thrombosis
  • Vessel and implant expansion (3% and 5% increase in mean area, respectively) and no loss of mean lumen area, demonstrating positive adaptive remodeling and the device’s ability to preserve blood flow over time
  • Mean acute gain of 1.63 mm (± 0.34), demonstrating radial strength
  • In-device mean late lumen loss of only 0.12 mm (± 0.18), demonstrating the ability of the device and drug coating to inhibit disease progression

“The innovative DynamX bioadaptor design was shown to match current drug-eluting stents in acute performance while offering the promise to improve upon the high adverse event rates that continue beyond year one with DES,” stated Dr. Verheye in the company’s press release. “In all measures, including clinical, QCA, IVUS, OCT, the bioadaptor demonstrated excellent performance and safety.” Dr. Verheye, who serves as Coprincipal Investigator of the study, is senior interventional cardiologist at the Antwerp Cardiovascular Center/ZNA Middleheim in Antwerp, Belgium.

Coprincipal Investigator Antonio Colombo, MD, commented in the announcement, “Coronary arteries naturally have the ability to expand with disease progression in order to maintain blood flow to the heart. Drug-eluting stents cage the coronary arteries and hinder this physiological response. DynamX is the first metallic coronary artery implant to demonstrate positive adaptive remodeling of the vessel, enabling it to expand to accommodate disease progression. This may improve longer-term clinical outcomes.” Dr. Colombo is Director, Cardiac Catheterization Laboratory, Columbus Hospital in Milan, Italy, and Coordinator, Cardiac Catheterization Laboratories GVM Group, Care and Research, in Lugo (Ravenna), Italy.

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