On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia.
The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year.
“Over the past decade, we’ve seen significant advancements in the treatment of peripheral artery disease, yet clinical and economic outcomes still present an opportunity for innovation and to improve patient care,” Jeff Mirviss, SVP & president of Boston Scientific’s peripheral interventions business, said in prepared remarks. “With the FDA’s approval of the Eluvia stent, we can now bring the transformative power of sustained drug release to clinicians and the millions of patients suffering from this terrible disease.”
The U.S. regulatory agency’s approval is based on data from Boston Scientific’s Imperial trial. In this study, researchers evaluated Eluvia against Cook Medical‘s Zilver PTX drug-eluting peripheral stent.
The 465-patient study was the first head-to-head trial comparing two different drug-eluting stents for the treatment of PAD.
Participants treated with Boston Scientific’s device had a 12-month primary patency rate of 88.5% compared to 79.5% in patients treated with the Zilver PTX device. Boston Scientific also reported that people treated with the Eluvia stent experienced half the target lesion revascularization rate of Zilver PTX after one year – 4.5% for the Eluvia group compared to 9% for the Zilver group.
“In the Imperial trial, the Eluvia stent demonstrated landmark vessel patency and freedom from target lesion revascularization rates, preventing more than 95% of patients from needing a reintervention after one year,” co-principal investigator Dr. William Gray said in a prepared statement. “The Eluvia stent is a breakthrough therapy that marks a significant step forward in the treatment of peripheral artery disease, and now with its approval and commercial availability, it has the potential to make an immediate impact on the quality and value of care that physicians can provide to their patients.”
Biotronik touts two-year data for Orsiro versus Xience drug-eluting stent
Biotronik this week touted two-year data for the Bioflow-V trial comparing Orsiro with Abbott‘s (NYSE:ABT) Xience drug-eluting stent.
The data from the 1,334-patient pivotal U.S. trial showed statistically improved outcomes for patients treated with Biotronik’s Orsiro drug-eluting stent across an array of endpoints.
Participants treated with Orsiro had a 7.5% target lesion failure rate after two years compared to an 11.9% rate for those in the Xience cohort.
People in the Orsiro group had a 2.6% target lesion revascularization rate compared to 4.9% in the Xience group, according to Biotronik. The company also reported a 0.1% stent thrombosis rate for the Orsiro group, versus 1% for the Xience group.
“These two-year results confirm the superior outcomes for Orsiro we identified at one year, now across an even broader range of clinical endpoints,” principal investigator Dr. David Kandzari said in prepared remarks.
Abbott’s Xience drug-eluting stent has traditionally been the standard of comparison in trials, according to Kandzari. The device, which features a thickness of 81 microns, uses a polymer that controls drug release over a period of three months.
Biotronik’s Orsiro device is 20 microns thinner than Abbott’s Xience product and features a bioresorbable polymer that dissolves off the stent over 12-24 months.
Beyond the sustained efficacy outcomes, Kandzari said the study’s findings point towards another possibility for the field.
“Might we look towards new standards of comparison for future drug-eluting stents and scaffolds?”
Medtronic touts safety, efficacy of Resolute Onyx compared to Biotronik’s Orsiro stent
Medtronic (NYSE:MDT) reported results from the first all-comers analysis of a 2,500-patient study comparing the safety and efficacy of its Resolute Onyx drug-eluting stent with Biotronik‘s Orsiro drug-eluting stent.
After one year, patients with coronary artery disease who were treated with Orsiro’s biodegradable polymer DES experienced no clinical advantage compared to patients treated with the Resolute Onyx device. Medtronic also noted that people treated with the Orsiro product had a higher rate of stent thrombosis.
“We have yet to see any meaningful clinical benefit with the introduction of biodegradable stent technologies,” Dave Moeller, VP & GM of Medtronic’s coronary & renal denervation unit, said in prepared remarks. “The Resolute Onyx DES has been shown to deliver excellent outcomes for a wide range of patients, and we are pleased to see that the combination of visibility, thin struts, conformability, and biocompatibility resulted in a very low stent thrombosis rate in this study.”
Medtronic highlights three-year data for In.Pact Admiral drug-coated balloon
Medtronic (NYSE:MDT) touted data for its In.Pact Admiral drug-coated balloon in people with peripheral arterial disease.
The medtech titan presented three-year real-world data from the full cohort of the In.Pact Global Study at the annual meeting of the Cardiovascular & Interventional Radiological Society of Europe. One-year data from the Total In.Pact pooled imaging and propensity analyses were presented at TCT.
In the In.Pact Global study, the real-world patient cohort’s rate of freedom from clinically-driven target lesion revascularization was 76.9%. With a mean lesion length of 12.09 ± 9.54 cm, participants also had 18% in-stent restenosis and 35.5% occluded lesions.
Medtronic reported that the the proportion of patients that underwent major target limb amputations was 0.8%.
One-year imaging data presented at TCT showed that treatment with the In.Pact Admiral DCB resulted in superior patency and freedom from CD-TLR compared to traditional PTA.
Supraflex sirolimus-eluting stent stands up to Abbott’s Xience device
The India-made Supraflex sirolimus-eluting stent proved non-inferior against Abbott‘s (NYSE:ABT) Xience device in a randomized trial conducted in Europe, according to data presented at this year’s TCT meeting.
Patients treated with Supraflex in the Talent trial had a 4.9% rate of cardiac death, target-vessel MI and clinically-indicated TLR at 12 months. Participants treated with Xience had a 5.3% rate of the same composite endpoint.
“The study results have important economic implications in countries with capped stent prices such as India, and in some European countries with competitive pricing and different models of healthcare cost savings,” study chair Dr. Patrick Serruys said, according to TCTMD.
“Since clinical outcomes of contemporary drug-eluting stents are reaching a safety plateau, it is likely that cost-effectiveness will influence, in the near future, the stent market,” he noted.
Biosensors’ drug-coated stent tops bare-metal stent at one year
Biosensors International‘s (PINK:BSNRY) drug-coated stent outperformed a bare-metal stent at one year, according to research touted at this year’s TCT meeting.
The trial was designed to support registration of Biosensors’ device in the U.S.
Researchers evaluated data from 1,189 people who received a bare-metal stent and 1,148 people who received a drug-coated stent. The primary safety endpoint was a composite of cardiac death and MI at one year and the primary efficacy endpoint was CD-TLR at one year.
The primary safety endpoint occurred in 12.3% of patients in the bare-metal stent group and 8.6% in the drug-coated stent group.
The primary efficacy endpoint occurred in 9.3% of participants in the bare-metal stent group and 6.1% of people in the drug-coated stent cohort, according to Healio.
