Elixir Medical Corporation

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Elixir looks to future of bioresorbable scaffolds

By AMANDA PEDERSEN, Senior Staff Writer
Medical Device Daily  |  December 2012 View original article (PDF)

Elixir Medical (Sunnyvale, California) started out in 2005 in the interventional cardiology space with the goal of having the broadest portfolio of drug eluting stents (DES) on the market to address as many patients as possible, Elixir CEO Motasim Sirhan told Medical Device Daily. Today it seems the company is right on target with its goal.

So right from the get-go the company’s portfolio included a bioresorbable eluting stent, Sirhan said, referring to the company’s DESolve novolimus eluting bioresorbable coronary scaffold system. The scaffold is designed to resorb in the body within one to two years after implantation and return the patients’ coronary vessel to de novo state.

Bioresorbable scaffold technology had thus far been a challenge in the industry because it required a level of strength and support that only permanent metallic stents had been able to provide, the safe and gradual bioresorption of the scaffold once the blood vessel healed, and for excellent clinical outcomes. The DESolve novolimus eluting bioresorbable coronary scaffold holds the promise to overcome these challenges, Elixir noted.

“We have the lowest drug dose on our DES platform, the thinnest polymer load, and the thinnest stent struts,” Sirhan told MDD. He added that these qualities of the device have led to “exceptional clinical outcomes at six to nine months, but also sustainable outcomes . . . those differentiate us from comparable available technology today.”

In late October Elixir reported enrollment completion of its 120-patient, pivotal clinical trial evaluating the safety and effi cacy of the DESolve novolimus eluting bioresorbable coronary scaffold system. Patient follow-ups are expected to be completed by the end of this year, the company noted.

The primary safety endpoint of the DESolve Nx trial is the composite of major adverse cardiac events (MACE) comprised of cardiac death, target vessel myocardial infarction (MI) and clinically-indicated target vessel revascularization (TLR). The primary angiographic endpoint of the trial is in-stent late lumen loss at six months as assessed by quantitative coronary angiography (QCA). In a sub-set of patients, additional QCA assessment will be conducted at 24 months; stent and vessel assessment using intravascular ultrasound (IVUS), optical coherent tomography (OCT) will be conducted at baseline, six and 24 months; and multi slice CT (MSCT) at 12 months thus providing long-term assessment of the scaffold and surrounding vessel.

“Bioresorbable drug eluting scaffolds that effectively treat the coronary artery obstruction without leaving a permanent metallic implant behind in the long term are undoubtedly the next frontier for interventional cardiology,” said Stefan Verheye, MD, PhD, ZNA Middleheim Hospital (Antwerp, Belgium), and principal investigator of the DESolve Nx study. “Having used the DESolve bioresorbable scaffold system in two clinical studies, and observed its
impressive performance, I am confi dent that Elixir’s DESolve scaffold system can achieve and maintain excellent longterm clinical outcomes.”

The DESolve scaffold made from a proprietary poly-L Lactide (PLLA)-based polymer provides optimal strength and support to the artery while delivering the novel antiproliferative drug, novolimus. Some unique features of the DESolve scaffold design as demonstrated in preclinical testing include (a) the ability to self-appose to the vessel wall in cases of malapposition; (b) the ability to maintain radial strength and vessel support for the critical period of vessel healing while bioresorbing within 12-24 months; and (c) a wide margin of scaffold expansion without strut fracture. The multi-center, prospective DESolve Nx trial was designed to enrolled 120 patients at 15 centers in Germany, Belgium, Poland, Brazil and New Zealand. Enrollment completion of the trial follows “outstanding results” of Elixir’s DESolve fi rst-in-man study wherein at six months, the DESolve demonstrated excellent late lumen loss of 0.19 ± 0.19 mm, no artery blockage (0.0% binary restenosis), no late malapposition (0.0%), low acute recoil (6.4% ± 4.3), no cases of blood clots (0.0% stent thrombosis), and a single MACE event due to a stenosis in the segment 5 mm proximal to the scaffold, which itself was widely patent, the company reported.

In late October, Alexandre Abizaid, MD, PhD, from the Instituto Dante Pazzanese de Cardiologia (Brazil), conducted a live case from Sao Paulo of a patient enrolledin the DESolve Nx trial undergoing six-month follow-up. The angiographic, IVUS, OCT, and MSCT imaging of the coronary vessels treated with the fully bioresorbable DESolve scaffold was projected live in the main arena at the annual Transcatheter Cardiovascular Therapeutics (TCT) meeting in Miami. The coronary vessels of the patient were widely patent, and these results were well received by an expert panel of cardiologists at TCT.

The device’s ability to self-appose to the vessel wall, or self-correct, is one of the key differentiating features of the DESolve scaffold system, Sirhan said. He also noted that the device’s ability to fully resorb in the body within one to two years makes its resorbable rate about half the time of competing devices. Finally, he said the scaffold comes in a full range of sizes without limitations in manufacturing ability.

“The feedback that we’re getting [from physicians in the fi eld] is that they’re recognizing that we have the deepest and broadest portfolio of any company in the industry,” Sirhan said. He noted that the case presented at TCT was a very difficult case and its successful outcome reinforces the technology’s performance ability.

“We look [to be] the future of resorbable scaffolds,” Sirhan said. “We feel our technology to be the most advanced, faster resorbable times by about half the time, self-directing scaffold properties to allow it to have a user-friendly deployment . . . puts us into a position of really getting this technology into” the mainstream marketplace.

Elixir also recently reported excellent long-term results of its CE mark-approved DESyne novolimus eluting coronary stent system compared to the control Endeavor zotarolimus eluting coronary stent system in the EXCELLA II randomized clinical trial at the three-year endpoint (Medical Device Daily, Oct. 26, 2012).

At three years, device-oriented composite endpoints (DoCE), a measure of major adverse events, for Elixir’s DESyne were exceptionally low and essentially unchanged through one, two and three years (4.3%, 4.3% and 5.0%) while the control Endeavor increased yearly (7.0%, 9.9% and 12.7%) with a trend towards statistical signifi cance (p=0.057). TLR rates at three years were signifi cantly lower in favor of the DESyne stent as compared to the control (1.4% vs. 9.9%;
p=0.008), the company noted.

Elixir’s DESyne stent elutes the m-tor inhibitor compound novolimus. According to Elixir, it is the first drug eluting stent to successfully combine the thinnest durable polymer coating, the lowest drug dose, and thin stent struts
to achieve excellent clinical outcomes as compared to other commercially available DES systems, the company said. The EXCELLA II trial had previously demonstrated both noninferiority and superiority of DESyne compared to Endeavor
for the primary endpoint of in-stent late lumen loss at nine months.

“We look forward to completing follow-up phase for DESolve and fi ling for CE mark approval and then looking for getting our IDE submission and approval completed in 2013 for DESyne and looking at demonstrating more of the clinical trial benefi ts of our scaffold,” Sirhan told MDD when asked about the company’s goals for the new year.