By Sarah Faulkner & Fink Densford
Surmodics (NSDQ:SRDX) touted data this week from an early feasibility study of the company’s SurVeil drug-coated balloon in patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries.
All of the study’s 13 subjects met the acute success measures of safety at 12 months, Surmodics reported, and no participants required re-intervention of either the target lesion or the target vessel.
The data also supported improvements in Rutherford classification, resting ankle brachial index and walking impairment after 12 months.
“The ongoing positive results from this study demonstrate that the SurVeil DCB has the potential to be a next-generation DCB with improved efficacy of drug transfer,” co-principal investigator Dr. Kenneth Rosenfield said in prepared remarks. “These 12-month data continue to support the functionality and safety of the device.”
“Our goal all along with the SurVeil DCB has been to advance the technology to improve drug transfer and distribution effect on the arterial wall offering the opportunity to use a lower drug dose,” president & CEO Gary Maharaj added. “We are pleased with the ongoing results from the EFS and look forward to the opportunity to continue to demonstrate the potential for this technology with outcomes from our pivotal Transcend clinical trial that is currently underway.”
Earlier this year, Abbott (NYSE:ABT) inked a deal to pay $25 million upfront for the global commercialization rights to Surmodic’s SurVeil drug-coated balloon as a treatment for PAD in the superficial femoral artery.
According to the deal, Abbott could also negotiate agreements for Surmodics’ below-the-knee and arteriovenous fistula drug-coated balloons, which are still in pre-clinical development.
The results were presented in a late-breaking scientific session by principal investigator Dr. William Gray of Lakenau Heart Institute, the Wayne, Penn.-based company said.
“The TOBA II study is unique in that it is the first large scale pivotal evaluation in peripheral arterial vessels that are 100% dissected following initial angioplasty and treated with a precisely targeted implant. This study introduces a new therapeutic paradigm, demonstrating that we can repair dissected arteries, leaving minimal metal behind to preserve future treatment options for our patients, and producing excellent 12-month outcomes,” Dr. Gray said in a prepared statement.
Intact Vascular touted that the trial is the first peripheral vascular study to enroll patients with 100% dissected vessels.
Investigators in the trial analyzed the use of the Tack endovascular system in repairing post-angioplasty dissections in the femoropopliteal arteries of 213 peripheral artery disease patients with underwent balloon angioplasty and experienced at least one dissection. A total 69.4% of the patients had dissections classified as severe.
Data from the study indicates a 92.1% rate of complete dissection resolution within a clinically challenged patient population. Results also indicated a 79.3% K-M vessel patency rate and an 86.5% K-M freedom from clinically driven reintervention at one year.
Intact Vascular said the trial also validated that the Tack implants are “stable and durable,” experiencing 0 implant fractures, a 99.9% freedom from migration and 0.5% bailout stent rate.
“As presented today, the TOBA II data further augment the growing body of evidence supporting the idea that a purpose-built implant for dissection repair can enhance the clinical results of balloon angioplasty. The Tack Endovascular System is also well aligned with a primary goal of endovascular operators: to leave as little metal behind as possible,” prez & CEO Bruce Shook said in a press release.
Cook Medical this week released results from an aggregated data analysis of its Zilver PTX drug-eluting peripheral stent, touting benefits in challenging patient populations.
In the analysis, researches examined data from nearly 2,400 patients in 16 countries who had participated in one of five Zilver PTX studies, including three pre-market studies in North America, Asia and Europe and two post market studies in the U.S. and Japan.
Investigators aimed to identify the impact of patient and lesion factors on freedom from total lesion revascularization at one year.
Results from the trial indicated that factors that would typically be expected to impact reintervention rates did not have an impact on reintervention rates for patients treated with the Zilver PTX stent. Those factors include Rutherford classification, sex, calcification and diabetes, Cook Medical said.
“It’s generally thought that sex, calcification and diabetes may have an impact on TLR, but this data demonstrates that these factors do not. In this global analysis of Zilver PTX patients, these characteristics did not have a significant impact on TLR. With an unrivaled five years of data gathered from these studies, Zilver PTX has shown long-term benefits in real-world outcomes. This is a significant amount of data that informs how we continue to work alongside physicians to fight this disease. We’re committed to helping patients who deal with the impact of PAD on their lives,” ,” Cook Medical vascular division VP Mark Breedlove said in a press release.
BTG (LON:BTG) today presented two-year results from the Sentry trial of its BTG Sentry bioconvertible inferior vena cava filter, touting protection against pulmonary embolisms and zero instances of tilt, perforation, migration or embolization.
Data from the trial was presented by principal investigator Dr. Michael Dake, and included data from 85 patients followed for two years with results verified with computed tomography or CT venography imaging.
Results indicated that the rate of freedom from new symptomatic PE through 60 days was 100%, with no cases of device-related, new symptomatic PE through to two years.
No instances of filter tilt, migration, embolization, fracture or IVC perforation were reported out to two years. Two patients in the trial developed symptomatic caval thrombosis in the first month, but neither experienced recurrence after interventions and no further instances occurred at two years. No instances of IVC stenosis were reported.
Filter bioconversion was achieved in 95.7% of patients at six months, 96.4% at 12 months and 96.5% at 24 months.
“This long-term data marks a paradigm shift in pulmonary embolism protection and is exactly why we brought the BTG Sentry to market. The trial shows no device-related pulmonary embolism and zero stability complications. Physicians can have the peace of mind that they are protecting their patients from the devastating consequences of PE while reducing complications often associated with IVC filter retrieval. This device eliminates the need to retrieve and that truly makes it a next-generation device,” BTG chief commercial officer John Sylvester said in a press release.
VIVA 2018 late-breakers: Day One
A number of major players in medtech presented research this week at VIVA Physician’s annual VIVA meeting in Las Vegas.
Included in the first day are results from Medtronic’s 5-year IN.PACT SFA trial; one year TOBA-II trial results from Intact Vascular; data from a study exploring gender differences in treatment for femoropopliteal artery disease with Philips’ Stellarex DCB; one-year results from Cook Medical’s Eluvia imperial long lesion subset; and a one-year pooled analysis from a study of Medtronic’s In.Pact Admiral DCB. Read the full results here.
Afternoon sessions at the conference provided more late-breaking data, including 18 month results from the DETOUR 1 trial of PQ Bypass’ PQ Detour system; a pooled data analysis from nearly 2,400 patients from trials of Cook Medical’s Zilver PTX DES; 12-month data from the PREVEIL study of Surmodics SurVeil DCB in treating de novo lesions of the femoropopliteal artery in symptomatic PAD patients; and results from a study of Veryan Medical Limited’s BioMimics 3D nitinol stent intended to treat patients with femoropopliteal disease. Read the full results here.
VIVA 2018 late-breakers: Day Two
The second day of VIVA 2018 saw a wealth of new scientific data from some of the biggest players in Medtech.
Late-breaking trials from the morning of the second day include six-month results from a Becton Dickinson below-the-knee study of its Lutonix 014 DCB; first-in-man data from Rex Medical’s Large Bore Closer vascular sealing system; results from a two-year analysis exploring the safety and effectiveness of BTG’s BTG Sentry IVC filter; 12-month results from the PERFECT registry studying pan-pelvic endovascular interventions for erectile dysfunction; and one-year safety and efficacy data from the VMI-CFA trial of Abbott’s Super vascular mimetic peripheral stent system. Read the full results here.
The final late-breaking trials form VIVA 2018 include results from BD’s Vernacular trial of its Venovo venous stent; first-in-human results from a trial of Reflow Medical’s Temporary Spur Stent System in treating BTK disease; six-month results from the Copper BTK Cohort study of Advanced Catheter Therapies’ Occlusion Perfusion cath; a trail exploring the use of Juventas Therapeutics intramuscular JVS-100 as an adjunct to revascularization for non-healing wounds; and results from a study of Exam Medical’s B-Laser novel atherectomy catheter. Read the full results here.
Check here for more coverage of VIVA 2018:
- Trial shows BD balloon compares well with angioplasty for CLI
- Medtronic touts five-year data for In.Pact Admiral drug-coated balloon
- Boston Scientific’s Eluvia drug-eluting stent succeeds in long lesions