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Adagio Gives Afib Cold Treatment in Hot Market
Adagio Medical is vying to get its treatment for persistent atrial fibrillation treatment on the market. The Laguna Hills, CA-based company made significant progress toward the goal this week and announced it received an IDE from FDA. The firm is developing a catheter procedure involving an energy source that freezes tissue. Adagio said its intelligent continuous lesion ablation system (iCLAS) encompasses the One- Shot+ catheter, a corresponding console, and a protective esophageal balloon to mitigate the effects of the cold beyond the localized area of ablation. The anatomical approach requires a single transseptal punctu...
Source: MDDI - August 20, 2019 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Another Chance for Medtronic ’s Renal Denervation Therapy
Medtronic has yet another chance to prove its renal denervation therapy can treat uncontrolled hypertension. The Dublin-based company has received FDA approval to begin a clinical trial to evaluate the Symplicity Spyral renal denervation system with patients on medication for high blood pressure. The ON MED Trial is a 2:1 randomized, sham-controlled study and will randomize up to 340 patients at 55 centers in the U.S., Japan, Europe, Australia and Canada. Patients will be followed out to three years. Primary safety endpoints will include major adverse events at one month and new renal artery stenosis at six months. The pri...
Source: MDDI - November 8, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study had had a previous aortic valve replacement. Such patients have been excluded from most TMVR trials because of the potential risks of left ventricular outflow tract obstruction or interaction between the TMVR anch...
Source: Mass Device - October 16, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Cardiac Implants Cardiovascular Featured Replacement Heart Valves Research & Development Mayo Clinic neovasc Neovasc Inc. Source Type: news

Medtronic ’s HVAD System Just Became Less Invasive
Medtronic has gained FDA approval for a less-invasive implant approach of its HVAD System, a left ventricular assist device (LVAD) for advanced heart failure patients. The Dublin-based company picked up the technology when it acquired HeartWare in 2016. The firm said the technology is the only LVAD approved in the U.S. for implant via thoracotomy, a small lateral, surgical incision between the patient's ribs on the left side of the chest. FDA approval for HVAD implantation via thoracotomy is based on data from the LATERAL prospective clinical trial, in which 144 patients, with end-stage heart failure who were eligible for ...
Source: MDDI - July 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Business Source Type: news

Medline buys Canadian stroke rehab device maker NeuroGym
Medline has acquired physical therapy and rehabilitation equipment maker NeuroGym Technologies of Ottawa. NeuroGym’s equipment is designed for people who have had a stroke or other traumatic brain injury, spinal cord injury, chronic neurological conditions such as multiple sclerosis, balance issues and/or the need for fall prevention therapy. The equipment requires the patient to initiate movement, which the company says can help rewire the brain and speed recovery. It includes a sit-to-stand trainer, bungee mobility trainer to re-teach walking and improve balance, a pendulum stepper for lower extremity strength and r...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Source Type: news

Bioness launches StimRouter neuromod system in Canada
Rehabilitation device maker Bioness today touted the launch of its StimRouter neuromodulation system in Canada, and said that the system had been implanted in its first procedures in the region. The first implantations of the device were performed at Toronto’s Women’s College Hospital, the Valencia, Calif.-based company said. “Significant advances in the miniaturization and durability of neuromodulation devices have provided interventional pain physicians with the right tools, like the StimRouter PNS System, to treat chronic pain related to nerve injuries, trauma, stroke and other irreversible damages wi...
Source: Mass Device - June 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neuromodulation/Neurostimulation Bioness Source Type: news

MassDevice EuroPCR 2018 Roundup
Valve Tech Roundup – Transcath heart valves getting safer, seeing expanded use   Abbott touts initial data from Portico TAVR study Abbott (NYSE:ABT) today released 30-day data from a study of its Portico transcatheter aortic valve replacement, touting excellent clinical outcomes and low rates of death, disabling stroke and paravalvular leak. The real-world, multicenter, prospective, single-arm Portico I study aimed to explore the safety and efficacy of the Portico valve with independent adjudication of clinical events and independent echocardiography core-lab analysis. Investigators in the study will follow pa...
Source: Mass Device - May 22, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Abbott Edwards Lifesciences Esaote Source Type: news

Stroke Rehab Technology Aims To Speed Healing
Watching someone who has suffered a stroke try to perform everyday actions such as walking down the sidewalk or even bringing a cup to their lips can serve as a sobering reminder of how fragile full and robust health is, and also serves as an inspiration for those dedicated to improving the lives of those patients. Steven Plymale, recently named CEO of Toronto-based MyndTec, said his reaction to watching videos of patients using the company's MyndMove functional electrical stimulation (FES) rehabilitation system was one of the reasons he joined MyndTec. "They are very compelling," Plymale said of the demonstration videos,Â...
Source: MDDI - November 22, 2017 Category: Medical Devices Authors: Greg Goth Tags: Electronics Source Type: news