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Source: Mass Device
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Total 237 results found since Jan 2013.
SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver
SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device.
In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated with the next-gen C2 driver, was not a recall notice, and that hospitals should continue to use the C2 driver without restriction.
SynCardia also said that the C2 Driver had not been identified as the root cause of the issues, which included higher rates of mortality and cerebr...
Source: Mass Device - August 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news
Report: Amazon adds MGH cardiologist Majmudar | Personnel Moves – August 21, 2018
Amazon (NSDQ:AMZN) has picked up well-known cardiologist Dr. Maulik Majmudar for a new role within the company as it looks to continue its foray into healthcare, according to a recent CNBC report.
The announcement was made by Majmudar himself on Twitter, according to the report, though he did not state what his specific role within the company will be.
Prior to joining Amazon, Majmudar served as the associate director of Massachusetts General Hospital’s healthcare transformation lab and lectured at the Massachusetts Institute of Technology, according to the report.
Majmudar has advised tech companies in the past, accord...
Source: Mass Device - August 21, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Abbott Amazon BioCardia BioSig Technologies Endologix johnsonandjohnson Lantheus Lumendi Nuvasive personnel-moves Rox Medical royalphilips SetPoint Medical Steris Corp. Xtant Medical Source Type: news
FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller
The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System.
Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study indicated that patients treated with the previous generation driver of the device, the Circulatory Support System Console, experienced a lower rate of stroke and mortality compared with the C2.
The TAH-t system is designed to function as a bridge to a heart transplant...
Source: Mass Device - August 20, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) SynCardia Source Type: news
Rapid Medical wins CE Mark for Tigertriever 13 stent retriever
Neurovascular device maker Rapid Medical said it won CE Mark approval in the European Union for its Tigertriever 13 stent retriever intended for treating ischemic stroke, and added that the first patient in the region has been treated with the device.
The Israel-based company touted the Tigertriever 13 as the first-ever fully-visible stent retriever that can be adjusted by the physician to fit in the dimensions of the blocked blood vessel.
Rapid Medical said that the device’s profile is 83% smaller than any other devices on the market, and that it is designed to recanalyze intracranial vessels of between 1mm and 2....
Source: Mass Device - July 31, 2018 Category: Medical Devices Authors: Fink Densford Tags: Regulatory/Compliance Vascular rapidmedical Source Type: news
NIH director Collins touts AF detection capabilities of iRhythm ’ s Zio ECG patch
iRhythm Technologies‘ Zio ECG patch won praises from NIH Director Dr. Francis Collins this week for its ability to aid in the detection of atrial fibrillation.
In an NIH Director blog post, Dr. Collins warned that while the dangers of atrial fibrillation are known, many individuals do not know they have atrial fibrillation and therefore cannot receive appropriate care.
While doctors mainly screen for AFib by checking pulse, Dr. Collins recommended new mobile health technologies for detecting AF, including iRhythm’s Zio patch.
Results from the mSToPS trial of the patch, which Dr. Collins referenced, indicated that t...
Source: Mass Device - July 18, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Cardiovascular iRhythm Technologies Inc. Source Type: news
Stryker wins FDA approval for Surpass Streamline brain aneurysm device
Stryker (NYSE:SYK) said today that it won pre-market approval from the FDA for its Surpass Streamline flow diverter for treating certain types of brain aneurysm.
Kalamazoo, Mich.-based Stryker said the PMA covers the treatment of un-ruptured large and giant wide-neck aneurysms. It’s the second flow diverter to be approved for the U.S. market, after Medtronic (NYSE:MDT) won a nod from the federal safety watchdog for its Pipeline Flex device in 2015.
“The PMA approval of Surpass Streamline flow diverter in the U.S. is an important milestone for the division. It expands our commercial footprint into the flow di...
Source: Mass Device - July 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Food & Drug Administration (FDA) Neurological Regulatory/Compliance Wall Street Beat Stryker Source Type: news
Medtronic wins FDA nod for thoracotomy-based HVAD procedure
Medtronic (NYSE:MDT) said today it won FDA approval for thoracotomy-based implantation procedures with its HVAD left ventricular assist device, which it said is a less-invasive implantation approach.
The Fridley, Minn.-based medtech giant touted the approval as the first for any commercially available LVAD in the US, and said that the clearance came based on data from the Lateral clinical trial of the device.
The 44-patient trial met its primary endpoint of non-inferiority, with data indicating an 88.1% rate of survival at six months free from disabling stroke or device explant or exchange due to malfunction. Results also...
Source: Mass Device - July 11, 2018 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Medtronic Source Type: news
ReWalk Robotics amends soft exoskeleton research, licensing deal with Harvard
UPDATE: Corrected to reflect that ReWalk Robotics was amending an earlier deal.
ReWalk Robotics (NSDQ:RWLK) has inked a set of amendments to its collaborative research and exclusive licensing agreement with Harvard Collage related to the development of its soft-suit exoskeleton, according to a recently posted SEC filing.
Through the original collaborative deal, both groups will join to aid in the development of soft-suit exoskeleton technologies designed to treat lower limb disabilities, the Marlborough, Mass.-based company said. The suit is intended to treat stroke, multiple sclerosis, mobility limitations for the elderl...
Source: Mass Device - July 2, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Research & Development Robotics ReWalk Robotics 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
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
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
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
