Interventional cardiologists have used stents to keep the heart’s coronary arteries open for decades. Transitioning from bare-metal stents to drug-eluting stents in the early 2000s brought tremendous benefits for patients.
“But over the last 10 years, the technological progress and meaningful clinical improvements have plateaued,” Elixir Medical CEO Motasim Sirhan told Drug Delivery Business News.
“When you stent an artery today, you actually cage it and by caging it you are inhibiting the normal pulsatility of the artery and inhibiting its built-in mechanism of adaptive remodeling intended to slow disease progression and clinical events,” he explained.
So Sirhan’s 65-person company set out to create a device that has the therapeutic benefit of a drug-eluting stent, but also helps the vessel resume its natural healing process. And last night at the annual Transcatheter Cardiovascular Therapeutics meeting, Elixir Medical unveiled what the company is touting as a new class of drug-eluting stents.
The company’s DynamX device is a 71-microns thin cobalt-chromium drug-eluting stent with a biodegradable polymer coating that releases novolimus. Segments of the stent are held together by the polymer coating, which is designed to absorb in six months.
“After you open a diseased vessel and allow it to heal, you want a stent to uncage and conform to the vessel anatomy letting nature take over now that the vessel is open and healed, thereby continuing to reduce inflammation and irritation to the vessel wall. DynamX is uniquely designed to uncage and conform to the vessel anatomy,” Sirhan said.
The chief executive explained that when plaque builds up in an artery over time, the artery will naturally expand to compensate in a phenomenon known as adaptive remodeling. Metallic stents stop the artery from doing this, which could potentially accelerate disease progression in the process, Sirhan said.
But Elixir’s DynamX drug-eluting stent, as well as the company’s DESolve bioresorbable scaffold, is designed to help the vessel resume adaptive remodeling.
“When developing DynamX, we matched the acute performance of a DES, and then we configured DynamX to uncage at 6 months restoring the vessel normal pulsatility and adaptive remodeling, and it’s normal geometric configuration,” Sirhan said. “We successfully developed DESolve, the only BRS to demonstrate adaptive remodeling at 6 months. We are confident DynamX DES will demonstrate similar results in the clinic.”
The company plans to bring its DynamX device to the clinic soon, enrolling up to 50 patients in its first study.