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Source: Mass Device
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Total 467 results found since Jan 2013.
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
ReWalk Robotics expands ReStore soft exo-suit trial
ReWalk Robotics (NSDQ:RWLK) said today that it plans to expand the clinical study of its ReStore soft exo-suit device to five U.S. research centers.
The Marlborough, Mass.-based company expects to launch its ReStore device for stroke patients in Europe and the U.S. in the first half of 2019. The exo-suit is designed as a gait therapy solution, providing coordinated plantarflexion and dorsiflexion assistance to a patient’s foot and ankle. ReWalk plans to price the system at under $20,000.
Enrollment for the company’s multi-center study is ongoing. The five centers involved in the trial include the Shirley Ryan ...
Source: Mass Device - June 28, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Clinical Trials Neurological Robotics Wall Street Beat ReWalk Robotics Source Type: news
Appeals court slashes $50m from J & J stapler suit damages
Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon had approximately $50 million slashed from punitive damages it owes in a product liability suit over its PPH 03 hemorrhoid stapler, according to recently released court documents.
In December 2015, a California state jury awarded the plaintiff in the case, Florence Kuhlmann, $70 million in punitive damages on top of an initial $9.8 million in compensatory damages.
This week, the Court of Appeals for the State of California’s First Appellate District, Division Five, cut the punitive damages down to $19.6 million, or two times the compensatory damages it owes.
The court...
Source: Mass Device - June 15, 2018 Category: Medical Devices Authors: Fink Densford Tags: Product Liability Surgical Ethicon johnsonandjohnson Source Type: news
Terumo ’ s MicroVention wins expanded FDA indications for Sofia cath
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today it won FDA clearance for a new clinical indication for its Sofia catheter designed for intracranial access, now cleared for contact aspiration procedures to treat acute ischemic stroke.
The company said it won CE Mark approval in the European Union for the aspiration in 2015, and that the device has been used there and in other parts of the world to treat acute ischemic stroke.
“In my clinical experience the unequaled tracking performance and the increased reperfusion capability of the Sofia Catheter make a major difference when treating patients suff...
Source: Mass Device - June 12, 2018 Category: Medical Devices Authors: Fink Densford Tags: Catheters Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular MicroVention-Terumo Inc. 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
Keystone Heart launches new TriGuard embolic protection study
Keystone Heart said today it launched the second phase of its Reflect trial evaluating the safety and efficacy of its third-generation TriGuard cerebral embolic protection device.
In the trial, investigators will explore the use of the TriGuard 3 and its ability to protect a patient’s brain from emboli during transcatheter aortic valve replacement procedures, the Israel-based company said.
“Knowing what we now know about the significant risks of stroke and other neurological injury associated with TAVR and other cardiovascular procedures, there is a clear unmet clinical need for cerebral embolic protection devi...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Neurological Keystone Heart Source Type: news
Report: Extra insights, but no clear-cut answers from TAVR embolic protection studies
Data from two new studies has provided extra insights, but no clear-cut solution for predicting stroke and which patients should receive embolic protection devices during transcatheter aortic valve replacement procedures, according to a new Medscape report.
Results from a meta-analysis of 1,285 patients indicated that the use of embolic protection devices during TAVR procedures did not reduce mortality, but was associated with a lowered rate of stroke at 30 days, according to the report.
The decline was mainly driven by registry data and was not confirmed by randomized controlled trials, Medscape specified.
Stroke was repo...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Claret Medical Inc. Source Type: news
Terumo ’ s MicroVention wins PMA for LVIS neuro stents
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for a line of neurovascular stents.
Aliso Viejo, Calif.-based MicroVention said the federal safety watchdog approved its low-profile visualized intraluminal support devices for stent-assisted coil embolization of intracranial aneurysms.
Previously approved under a humanitarian device exemption, the LVIS and LVIS Jr. stents are designed to stabilize the blood vessel around the opening to a wide-neck aneurysm while a coil is deployed within the aneurysm and then retrieved after the coil is in place.
“The LVIS and...
Source: Mass Device - May 31, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular MicroVention-Terumo Inc. Source Type: news
EuroPCR 2018 Roundup: Medtronic touts BP reductions, no major adverse events in renal denervation trial
Medtronic (NYSE:MDT) today released six-month results from a trial of its Symplicity Spyral renal denervation system exploring its use treating hypertensive patients who are already taking anti-hypertension medications, touting significant reductions in blood pressure and no major adverse safety events.
Results were presented at the 2018 EuroPCR annual meeting in Paris and were published in The Lancet.
In the trial, patients were prescribed up to three anti-hypertensive medications, including diuretics, calcium channel blockers, ACE/ARB inhibitors or beta blockers, the Fridley, Minn.-based company said. Patients were then...
Source: Mass Device - May 23, 2018 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Cardiac Implants Cardiovascular Clinical Trials Abbott Medtronic ReCor Medical 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
J & J ’ s Cerenovus wins FDA nod for Embotrap II revascularization device
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus said today it won FDA 510(k) clearance for the Embotrap II revascularization device.
The Irvine, Calif.-based J&J division said that the device is designed to quickly restore natural blood flow by retrieving emboli within the vasculature of the brain, using minimal compression to protect against further complications.
Approval of the device came based on data from the Arise II study, in which investigators reported being able to restore blood flow in 80% of patients treated within three passes, and in approximately 50% within a single pass. More than 66% of patients ...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: 510(k) Food & Drug Administration (FDA) Neurological Regulatory/Compliance Vascular cerenovus johnsonandjohnson Source Type: news
Medtronic recalls select MindFrame Capture revascularization devices
The FDA today released a recall notice for a select number of Medtronic (NYSE:MDT) MindFrame Capture LP revascularization devices over issues with the delivery wire breaking or separating during use.
The federal watchdog labeled the recall as a Class I, its most serious class of recall, which indicates the potential for serious injury or death.
The Fridley, Minn.-based company’s MindFrame Capture LP device is designed to restore blood flow and remove blood clots within a blood vessel in the brain during acute ischemic stroke in patients who are ineligible or fail intravenous tissue plasminogen activator therapy.
Medtroni...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Neurological Recalls Vascular Medtronic Source Type: news
Philips, AHA, UPMC launch $30m heart-focused venture fund
Royal Philips (NYSE:PHG) said late last week it is joining with the American Heart Association and UPMC to launch a $30 million heart-focused collaborative venture capital fund.
The newly formed Cardeation Capital fund will support innovation in products for treating heart disease and stroke care. The fund will be managed by Aphelion Capital, with each major player contributing $10 million, Amsterdam-based Philips said.
Cardeation Capital will look to invest in companies trying to treat cardiovascular diseases and stroke and their risk factors, including diabetes, according to Philips.
“At Philips our goal is to imp...
Source: Mass Device - May 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular Wall Street Beat American Heart Assn. royalphilips UPMC Source Type: news
NeuroVasc Tech raises $6m in Series B
NeuroVasc Technologies said yesterday it closed a $6.3 million Series B preferred stock round.
The round was joined by multiple investors, and led by ShangBay Capital, the Laguna Hills, Calif.-based company said.
NeuroVasc Tech is developing treatments for neurovascular conditions with a focus on treating ischemic stroke, and currently has CE Mark approval in the European Union for its Versi mechanical thrombectomy system used to remove clots form the brain during acute ischemic stroke.
The device does not yet have FDA clearance for use in the US, the company said.
“NeuroVasc’s technologies may significantly im...
Source: Mass Device - May 17, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Funding Roundup Neurological Vascular NeuroVasc Technologies Source Type: news
Medtronic touts data from Micra pacer AV algorithm study
Medtronic (NYSE:MDT) late last week released data from a new clinical study of an algorithm used with its Micra transcatheter pacing system, touting that it has the potential to restore atrioventricular synchrony and improve cardiac function in patients with sinus rhythm and AV block.
Results from the study were presented at the Heart Rhythm Society’s annual scientific sessions in Boston, the Fridley, Minn.-based company said.
Researchers in the Marvel study examined the use of the algorithm, which uses the Mira pacer’s accelerometer signal, in 64 patients, Medtronic said. Investigators aimed to evaluate whether ...
Source: Mass Device - May 16, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Clinical Trials Medtronic Source Type: news
