Novel implant maintains flexibility of artery after procedure to treat CAD
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A novel drug-eluting coronary artery implant that “uncages” after 6 months appears to have similar short-term performance to a drug-eluting stent while maintaining flexibility of the treated artery, according to an early study in humans.
A single-arm study of 20 patients who received the novel implant (DynamX drug-eluting bioadaptor, Elixir Medical) was published in Cardiovascular Revascularization Medicine.
Preserving artery movement, function
“I believe the ideal device to treat coronary artery disease would completely preserve natural movement and function of the vessel. An optimal solution would be if you can achieve this with an implant that provides the support and radial strength that you need and restores the coronary motion and function,” Mladen I. Vidovich, MD, FACC, FSCAI, professor of medicine at the University of Illinois in Chicago and interventional cardiologist, chief of cardiology and director of the cardiac catheterization laboratory at Jesse Brown VA Medical Center in Chicago, told Healio. “By incorporating unique ‘uncaging elements’ in its metallic implant design, which are, in essence, flexible joints, the DynamX bioadaptor allows for the restoration of natural artery function and movement essential to cardiovascular performance. The DynamX bioadaptor is able to adapt to vessel physiology and restore positive adaptive remodeling, pulsatility and rotation. We have never seen drug-eluting stents that can restore vessel movement and function. The DynamX bioadaptor supports the coronary artery with radial strength and acute performance similar to DES during healing. However, unlike DES, the bioadaptor ‘uncages’ the artery after its polymer coating resorbs over 6 months. This uncaging enables the device to restore the artery’s ability to move naturally in response to the heart’s needs.”
In the study, the rotational uncaging of the bioadaptor reduced peak stress by 70%.
Using IVUS, the researchers determined that soon after the implant, the net-effect rotational motion of the implanted vessel was –2.7° compared with 0.5° for the native proximal vessel (P = .036) and 0.2° for the native distal vessel (P = .042).
However, Vidovich and colleagues determined using IVUS, after “uncaging” occurred, the net-effect rotational motion of the implanted vessel was –0.2°, which did not significantly differ from the native proximal and distal vessels.
Improved coronary rotation
“The study further confirmed that when you place a stent in a coronary artery [that] experiences rotational movement, there are stresses that build up in the implant and you restrict coronary rotation — that was no surprise,” Vidovich told Healio. “We studied the bioadaptor with intravascular ultrasound imaging of patients at 9- to 12-month follow-up, and we found that, after the bioadaptor uncaged over 6 months, the device significantly improved coronary rotation in the treated segment of their arteries.”
Vidovich told Healio that some coronary arteries, lesions and segments are more prone to rotation than others, including the left anterior descending artery and the mid-right coronary artery.
“It is very possible that some portions of stent failure in these areas may be due to the inability of the vessel to rotate with a stent in place,” he told Healio. “With what we learned in this study, it might be advantageous to consider using bioadaptors rather than stents in these regions of high or contradictory rotation to accommodate vessel movement. Also, patients with long lesions requiring treatment, which often affects diabetics, and younger, active patients could be good candidates to consider for the bioadaptor.”
The bioadaptor, which is not yet approved for commercial use in the United States, is being compared with DES in two head-to-head studies, BIOADAPTOR RCT and INFINITY-SWEDEHEART RCT, according to Elixir Medical.
For more information:
Mladen I. Vidovich, MD, can be reached at miv@uic.edu.
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