Elixir Medical touted clinical and imaging results from a study of its DynamX drug-eluting stent, which is designed to restore normal pulsatility and adaptive remodeling in blood vessels after treating a coronary lesion.
DynamX, introduced in 2017 at the annual Transcatheter Cardiovascular Therapeutics meeting, is a cobalt-chromium stent with a biodegradable polymer coating that releases novolimus. Segments of the stent are held together by the polymer coating, which is designed to fully absorb in six months. Results from the European Mechanistic study, including nine-month clinical data from 50 patients and and 12-month angiography and imaging results for 31 patients, were released at the annual EuroPCR meeting in Paris this week.
In-device mean late lumen loss was 0.08mm at 9 and 12 months; median LLL was 0.02mm as measured by qualitative comparative analysis, Milpitas, Calif.-based Elixir said.
Optical coherence tomography scans showed 99% strut coverage with a uniform 0.14mm neointimal layer. Intravascular ultrasound imaging showed mean vessel- and device-area increase in the treated segment from post-procedure to long-term follow-up, while maintaining mean lumen area.
“Elixir’s outstanding data demonstrate the engineering ingenuity of the DynamX bioadaptor for uncaging and restoring the vessel’s natural state to expand and accommodate disease progression, thereby maintaining the blood flow lumen and potentially reducing adverse clinical outcomes for patients,” co-principal investigator Dr. Antonio Colombo, of Milan’s Columbus Hospital, said in prepared remarks. “I’m delighted to treat my patients with a device presenting such impressive long-term results that far exceed [drug-eluting stent] capabilities and yet providing DES-like excellent acute performance.”
“Another key attribute for reducing adverse clinical events in patients is preserving the natural angulation of the coronary arteries,” added co-principal investigator Dr. Stefan Verheye, of Antwerp’s Middleheim Hospital. “Unlike conventional DES that tend to straighten angulated blood vessels due to their rigidity, Elixir’s novel DynamX bioadaptor demonstrated via multiple case studies its unique ability to restore the pulsatility, positive adaptive remodeling, and natural curvature of the treated arteries, allowing the vessels to elegantly return to their de novo function.”
“Elixir’s DynamX bioadaptor represents a pioneering innovation in coronary implant design for the PCI industry by combining the excellent acute performance of DES while categorically surpassing DES with its ability to return the vessel to its de novo state,” CEO Motasim Sirhan said. “Elixir is committed to raising the bar for treatment of cardiovascular disease, and providing physicians with innovative products of the highest standard of care to improve patients’ clinical outcomes.”
Biotronik claims win over Medtronic, Boston Scientific in three-year small vessel study
Biotronik said a study comparing its Orsiro sirolimus-eluting stent with the Medtronic (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent and the Synergy everolimus-eluting stent made by Boston Scientific (NYSE:BSX) in treating small vessels.
The rate of target lesion failure for the Orsiro-treated arm was 7.0%, compared with 10.0% for Resolute Integrity and 9.5% for Synergy, according to the study, presented at the conference and published in the Journal of the American Medical Assn. Although the rates of cardiac death and myocardial infarction were similar for all three DES, the Orsiro cohort had a 2.1% rate of repeat target lesion revascularizations, compared with 5.3% for the Resolute Integrity arm and 4.0% for the Synergy group.
When dual anti-platelet therapy was stopped at one year, the TLR rate for Orsiro was 1.0%, compared with 3.7% for Resolute Integrity and 2.7% for Synergy. The Orsiro cohort also showed a lower rate of definite or probable stent thrombosis, at 0.6%, than either Resolute Integrity or Synergy (both 1.5%).
“The results may be clinically relevant, as they suggest a relation between the use of ultrathin-strut sirolimus-eluting stents and a lower repeat revascularization risk in all-comers patients with small target vessels,” principal investigator Dr. Clemens von Birgelen, of Holland’s Thoraxcentrum Twente, said in prepared remarks. “Due to a greater relative impact of stent strut size on lumen obstruction, the substantially thinner struts of these new-generation drug-eluting stents may be particularly advantageous in small vessels.”
Biotronik said that 42.9% of the 3,514-patient Bio-Resort study subjects need small vessel treatment, which increases the risk of adverse events.
“The Bio-Resort outcomes add to the growing body of evidence that demonstrate ultrathin strut Orsiro provides real clinical advantages over second-generation, thicker-strut DES,” marketing SVP Alexander Uhl said. “These favorable results, together with the significant differences in efficacy shown in the SCAAR data at this EuroPCR, and Bioflow-V underscore that Orsiro is a tool every interventionalist should have access to.”
Pi-Cardia touts FIH Leaflex Performer study
Pi-Cardia touted first-in-human results for its Leaflex Performer device, which is designed to score calcified aortic valve leaflets ahead of transcatheter replacement procedures or as a standalone treatment.
The Rehovot, Israel-based company said the 16-patient study showed the safety and feasibility of the Leaflex scoring mechanism of action and “significant and substantially greater” hemodynamic improvement than balloon valvuloplasty, the company said.
“We were really happy to learn that a safe and simple procedure that takes less than 20 minutes can produce such a dramatic effect on valve function without leaving an implant behind. With these promising first-in-human data, we can now move on to the next set of trials to show long term durability of the effect,” co-principal investigator Dr. Peter Andreka said in prepared remarks. “We believe that if a simple, low-cost alternative existed, which could offer patients a reasonable period of time without symptoms, such a technique could have an important role alongside TAVR.”
Reducer results included statistically significant increases in myocardial perfusion reserve index using stress MRI testing and a statistically significant improvement in left ventricular ejection fraction in a 19-patient study, plus a statistically significant increase in six-minute walk tests at four months and improved Canadian Cardiovascular Society scores in 84% of patients; case reports on successful retrieval of a dislodged Reducer and implantation leading to a symptom-free outcome; and a suggestion that coronary sinus size may play a role in the success rate.
In a separate release today Neovasc said two-year data from a Reducer trial, published this week in the International Journal of Cardiology, bore out earlier safety and efficacy results but showed no effect on the progression of coronary artery disease.
Given that trans-apical Tiara is among the earliest TMVR devices, Dr. Lenard Conradi said “it is remarkable that its procedural safety profile is excellent, with no procedural mortality in a high-risk patient population. Also, in this early stage and compared to other devices, the delivery catheter is remarkably ergonomic and user-friendly.”
“The new data reported at this year’s EuroPCR for our Reducer provides us with exciting insights into the positive impact that the device has on treating refractory angina pain and other symptoms they might suffer from. Considering this patient population has limited therapeutic options, and suffer a serious impact on their quality of life, the more information we can provide treating cardiologists on the benefits of the Reducer, the more likely it is that this therapy will become a new standard of care for the treatment of refractory angina around the world,” president & CEO Fred Colen said in prepared remarks. “On the Tiara side, we also had an interactive and productive Tiara II meeting with our clinical investigators and a core-lab representative, plus we demonstrated our new transfemoral, trans-septal Tiara system in closed door sessions to invited interventional cardiologists and surgeons, with many lively discussions and positive and encouraging feedback. All in all, a very productive and exciting EuroPCR conference for Neovasc this year.”
Corindus touts live robotic CorPath GRX PCI case
Corindus Vascular Robotics (NYSE:CVRS) said its CorPath GRX robot-assisted device for percutaneous coronary interventions was used in a live case demonstration during the conference.
The May 22 PCI procedure was performed by Dr. Jean Fajadet at Toulouse’s Clinique Pasteur and broadcast live to the meeting, a European first for a CorPath GRX procedure.
“As robotic capabilities continue to advance, we are very pleased to share the latest developments in CorPath GRX with the attendees at EuroPCR,” president & CEO Mark Toland said in prepared remarks. “Dr. Fajadet is a pioneer of this technology in Europe and understands our ultimate vision of enhancing patient care through the advancement of our technology. In just a few short months, he has established his facility as a leader in vascular robotics and has demonstrated the positive impact of a high-tech care model to the clinical community in Europe.”
“CorPath GRX offers the level of precision and control necessary to perform even the most complex PCI procedures,” Fajadet added. “The live case went exactly as planned. I was able to complete the procedure with control of all interventional devices and imaging equipment from the control room, providing my patient with high-quality care while protecting myself and the cath lab team. I am pleased to share this technology with my peers to demonstrate how far it has come, and the promising future it may provide patients.”