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Source: Mass Device
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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
Neuravi raises $21m Series B for thrombectomy device
Neuravi said today that it raised $21 million in a Series B round for its Embotrap minimally invasive thrombectomy device.
“The intention of the funding round is to launch the device in Europe, to run the Arise program for the U.S., to attempt to bring the device for U.S. approval and to continue to develop further technologies in the field,” CEO Eamon Brady told MassDevice.com. “One of the things Neuravi has done that’s unique to all of our competition is we have launched a huge research effort over the last 5 years in understanding the properties of clots – the cause of ischemic stroke – an...
Source: Mass Device - June 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Cardiovascular Catheters Stents Life Sciences Partners Neuravi Limited Source Type: news
Silk Road touts TCAR study data
Silk Road Medical disclosed encouraging new clinical data for its Enroute device, which is cleared to help protect the brain from stroke while implanting a transcarotid artery stent.
The company said that additional data showed its Enroute transcarotid neuroprotection and stent system, indicated for transcarotid artery revascularization (TCAR), helped improve stroke and death rates in the wake of its FDA sign-off last October. Investigators from Massachusetts General Hospital and elsewhere presented their findings during the 2016 Vascular Annual Meeting of the Society for Vascular Surgery, which was held June 8-11 in Natio...
Source: Mass Device - June 15, 2016 Category: Medical Equipment Authors: Mark Hollmer Tags: Catheters Clinical Trials Stents Vascular Silk Road Medical Inc. Source Type: news
Neuravi raises $16.7m
Neuravi said today it raised $16.7 million (EU €15 million) in a new round of debt financing, with funds slated to support U.S. commercialization and portfolio expansion.
Money in the round came from healthcare alternative financing provider IPF Partners, the Galway, Ireland-based company said.
Funds raised in the round will be invested into the U.S. commercialization of its products and expanding its stroke treatment portfolio, Neuravi said.
“With the recent European launch of the EmboTrap II device and the excellent progress in enrolling our pivotal clinical trial, we are making significant headway in delivering...
Source: Mass Device - November 2, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Vascular Neuravi Limited Source Type: news
FDA green-lights Aegis Medical trial for Sierra ligation device
This study will confirm the safety of the Sierra device for patient use, and will lay a solid foundation for future efforts to demonstrate that Sierra can prevent stroke in AF patients and eliminate the need to take blood thinners for stroke prevention,” principal investigator Dr. Sheldon Singh of Toronto’s Sunnybrook Health Sciences Centre said in a prepared release.
“For many AF patients, anticoagulants are used to reduce the risk of stroke. One of the downsides of these drugs is that they can result in life-threatening bleeding. Aegis has developed a minimally invasive, non-vascular LAA closure device,...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Aegis Medical Innovation Source Type: news
ReWalk Robotics touts Harvard-led Restore soft exosuit study
ReWalk Robotics (NSDQ:RWLK) today released results from a study of a soft suit exoskeleton system designed to aid ambulatory stroke patients, touting that the system was able to facilitate normal walking ability in patients.
The study was authored by researchers at Harvard University’s Wyss Institute for Biologically Inspired Engineering and Boston University, and utilized a prototype that Marlborough, Mass.-based ReWalk Robotics plans to commercialize as the Restore system.
Results from the study were published in the Journal of Science Translational Medicine.
The Restore system is designed to transmit power to ke...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Prosthetics Robotics ReWalk Robotics Source Type: news
Penumbra touts non-inferiority in Compass aspiration thrombectomy trial
Penumbra (NYSE:PEN) late last month released results from the Compass trial of its aspiration thrombectomy system designed to treat acute ischemic stroke, touting that the system was shown to be non-inferior to stent retrievers.
Results from the trial were presented at the International Stroke Conference, the Alameda, Calif.-based company said.
Investigators in the trial aimed to compare the use of Penumbra’s aspiration thrombectomy system, which uses a suction to remove clots, against traditional stent retrievers in treating patients with acute ischemic stroke.
Results from the study indicated 52% of patients treat...
Source: Mass Device - February 8, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Vascular Penumbra Inc. Source Type: news
Silk Road Medical touts TCAR study data
Silk Road Medical today released results from studies of its transcarotid artery revascularization procedure, touting favorable outcomes in treating patients with carotid artery disease.
Data from the studies were presented at the Society for Vascular Surgery 2018 Vascular Annual Meeting in Boston.
The transcarotid artery revascularization procedure uses the Sunnyvale, Calif.-based company’s Enroute transcarotid stent and neuroprotection system, and is intended to treat blockages in the carotid artery that are at risk of causing a stroke.
Results from a two-year study which compared outcomes from 1,182 patients who r...
Source: Mass Device - June 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news
UPDATE: Silk Road Medical prices $120m IPO
Updated to include comment from CEO Erica Rogers
Silk Road Medical late yesterday priced its initial public offering, looking to raise approximately $120 million.
The Sunnyvale, Calif.-based company said it plans to float 6 million shares of its common stock at a price of $20 per share. The offering also includes a 30-day underwriters option to purchase an additional 900,000 shares of common stock.
Silk Road Medical produces the Enroute transcarotid neuroprotection and stent system, which is intended for use during the transcarotid artery revascularization procedure, or TCAR.
“The Enroute system is part of the devic...
Source: Mass Device - April 4, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Vascular Wall Street Beat Silk Road Medical Inc. Source Type: news
Penumbra launches Ace68 Reperfusion thrombectomy catheter
Penumbra today announced the U.S. launch of the Ace68 Reperfusion thrombectomy catheter designed for extracting thrombus in acute ischemic stroke patients.
The company said the Ace68 catheter was engineered on an entirely new platform from hub to tip, which features coil winding geometry along 16 transitions to create a more optimal tracking profile.
“With the Ace68 Reperfusion Catheter, I can easily deliver full aspiration power to the occlusion. The Ace68’s large lumen increases the likelihood of capturing the clot fully within the catheter or the canister, potentially reducing the number of passes to achieve ...
Source: Mass Device - July 25, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Business/Financial News Catheters Penumbra Inc. Source Type: news
Penumbra touts stent retriever study data
Penumbra (NYSE:PEN) said a 198-patient trial of its next-generation stroke-treatment device along with another company product showed promise, meeting primary endpoints. Results were positive enough that a 2016 regulatory submission remains part of the plan.
“The trial results are encouraging for our Penumbra 3D Revascularization Device, and we are focused on continuing our plan to pursue regulatory submission by the end of the year,” Penumbra Chairman and CEO Adam Elsesser said in prepared remarks.
“Furthermore,” Elsesser added, “the broader implications of the data support frontline use of t...
Source: Mass Device - July 28, 2016 Category: Medical Equipment Authors: Mark Hollmer Tags: Clinical Trials Stents Vascular Penumbra Inc. Source Type: news
Stryker ’ s Concentric Medical wins Class II FDA label for Trevo clot retrieval devices
The FDA today announced it has relabelled Stryker (NYSE:SYK) subsidiary Concentric Medical‘s Trevo mechanical thrombectomy devices as Class II.
Concentric Medical submitted a request for reclassification of the Trevo ProVe and XP ProVue retrievers in October last year, according to the FDA.
The federal watchdog reviewed the order, and said that on September 2 it issued an order to reclassify the device types, given the generic name of neurovascular mechanical thrombectomy devices for ischemic stroke treatment, as Class II.
In relabeling the devices, the FDA identified 5 possible risks, including adverse tissue rea...
Source: Mass Device - December 27, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Vascular Concentric Medical Inc. Stryker Source Type: news
7 medtech stories we missed this week: Feb. 24, 2017
[Photo from unsplash.com]Several companies made distribution deals this week, while others received approval for their products. Here are 7 medtech stories we missed this week but were still worth mentioning.
1. Israel OKs E-Qure’s BST device for chronic wounds
E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from the Israeli Ministry of Health, according to a Feb. 24 news release. BST is an electrotherapeutic method for treating chronic wounds. E-Qure will begin marketing its device in Israel by activating a signed distribution agreement with...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Electronic Medical Records Imaging Mergers & Acquisitions mHealth (Mobile Health) Regulatory/Clearance Align Technology Clarius Mobile Health Corin Group E-Qure Henry Schein Medical Nexstim Skyline Medical Source Type: news
EuroPCR 2017 Roundup: Boston Scientific ’ s Lotus beats Medtronic ’ s CoreValve in head-to-head study
Boston Scientific (NYSE:BSX) said its Lotus replacement heart valve beat the competing CoreValve device made by Medtronic (NYSE:MDT) in a head-to-head trial.
Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with the CoreValve and CoreValve Evolut devices in high- and extreme-risk patients.
The primary efficacy endpoint was the composite rate of death, disabling stroke and moderate or greater paravalvular leakage at 1 year; the primary safety endp...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Boston Scientific Edwards Lifesciences europcr2017 Medtronic Source Type: news
Report: New MRI technique improves brain scan accuracy
A new MRI technique could allow physicians to more accurately examine brain scans, according to an MIT News report.
Researchers at MIT, working with physicians at Massachusetts General Hospital and other institutions, have developed a way to boost the quality of the brain scans so that they can be used for large-scale studies on the effects of stroke and treatment responses, according to the report.
The scans could help researchers discover how genetic factors influence stroke survival, as well as serving as a new approach to understanding disorders such as Alzheimers, MIT News reported.
The new scanning approach involves ...
Source: Mass Device - June 22, 2017 Category: Medical Devices Authors: Fink Densford Tags: Imaging Neurological Source Type: news
