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Source: Mass Device
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Total 237 results found since Jan 2013.
Medtronic touts stroke data from HeartWare HVAD thoracotomy study
Medtronic (NYSE:MDT) today touted stroke data from the Lateral trial of its HeartWare HVAD left ventricular assist device involving implantation via thoracotomy instead of open surgery.
With a thoracotomy implantation, surgeons insert the pump via a small, lateral incision between the left ribs and make a second small incision to accommodate the pump’s outflow graft. Fridley, Minn.-based Medtronic said Lateral results presented at the annual meeting of the American Society for Artificial Internal Organs showed that 95% of thoractomy patients were free from disabling stroke at two years.
Adverse events were more like...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Cardiovascular Clinical Trials Featured Medtronic Source Type: news
Conformal Medical launches LAA seal study
Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients.
Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and without general anesthesia. The 45-patient, single-arm study is designed to evaluate the device’s performance, with an estimated primary completion date of April 2020 and a final completion date of June 2025, according to ClinicalTrials.gov.
Th...
Source: Mass Device - April 10, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Clinical Trials Featured Conformal Medical Source Type: news
Medtronic touts stroke data for HeartWare LVAD
A retrospective analysis of two studies involved the HeartWare left-ventricular assist device Medtronic (NYSE:MDT) acquired in 2016 showed that managing blood pressure reduced the severity of strokes in patients implanted with the HVAD pump.
The analysis, of “destination therapy” patients who are not candidates for a heart transplant, took data from the Endurance and Endurance Supplemental studies. Results were presented this week at the annual meeting of the International Society for Heart & Lung Transplantation in London, Medtronic said.
The 465-patient Endurance Supplemental study compared 308 patients i...
Source: Mass Device - April 5, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Assist Devices Clinical Trials Featured Abbott HeartWare International Inc. Medtronic stjudemedical Thoratec Corp. Source Type: news
ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II.
Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session 2019 in New Orleans and published simultaneously in the New England Journal of Medicine, the Chicago-area medical device company said.
Abbott touted its HeartMate 3 as the first implantable mechanical pump using fully magnetic levitation technology, making it fri...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Abbott Source Type: news
ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology.
Data from the trials were presented over the weekend at the American College of Cardiology 68th Annual Scientific Session 2019 in New Orleans and simultaneously published in the New England Journal of Medicine.
Currently, TAVR devices are only approved by the FDA for treating severe aortic valve stenosis in patients at inte...
Source: Mass Device - March 18, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Featured Replacement Heart Valves Edwards Lifesciences Medtronic Source Type: news
Boston Scientific wins CE Mark for Watchman FLX anti-stroke implant
Boston Scientific (NYSE:BSX) said today that it won CE Mark approval in the European Union for the next iteration of its Watchman anti-stroke heart implant.
The Marlborough, Mass.-based medical device maker said the Watchman FLX is designed to be easier to implant during procedures to occlude the left atrial appendage and is re-capturable and re-positionable intraprocedurally.
Watchman FLX is under limited release in Europe, with more sites slated to come on line during the second half of the year, Boston Scientific said. A European post-market registry study is also planned, the company said.
“The Watchman device h...
Source: Mass Device - March 13, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Cardiac Implants Featured Wall Street Beat Boston Scientific Stroke Source Type: news
Using wearable devices in clinical trials
Brandy Chittester, chief of clinical operations, IMARC
Globally, more than 325 million people own wearable, connected devices, and more than 2.5 billion own smartphones. Using wearable devices in clinical trials can bring huge benefits, however, there are also concerns.
Here’s a look at how researchers are using wearable devices — and what you should consider before using them in your own research.
How wearable devices are advancing medicine
Right now, ClinicalTrials.gov, a global database of clinical trials, lists nearly 200 trials with “wearable devices” or “wearable technology” in the description.
This in...
Source: Mass Device - March 12, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Blog IMARC Source Type: news
Silk Road registers for $86m IPO
Silk Road Medical has registered for an initial public offering, looking to bring in approximately $86.3 million, according to a recently posted SEC filing.
The Sunnyvale, Calif.-based company said that it applied to list its common stock on the NASDAQ exchange using the symbol “SILK,” according to the filing.
The company’s flagship product is its Enroute transcarotid stent and neuroprotection system, which is designed to be used during a transcarotid artery revascularization procedure to treat blockages in the carotid artery that are at risk of causing a stroke.
Funds from the offering will be used to ex...
Source: Mass Device - March 5, 2019 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Featured Initial Public Offering (IPO) Wall Street Beat Silk Road Medical Inc. Source Type: news
Study of Boston Scientific ’s Lotus, Medtronic’s CoreValve shows similar outcomes at 2 years
Two-year results from a head-to-head study comparing transcatheter aortic heart valve replacement devices from both Boston Scientific (NYSE:BSX) and Medtronic (NYSE:MDT) indicated similar outcomes for the competing products.
The study, published recently in the journal JAMA Cardiology, compared Marlborough, Mass.-based Boston Scientific’s Lotus valve to Fridley, Minn.-based Medtronic’s CoreValve system.
Investigators in the study compared outcomes for 912 patients with high or extreme risk and severe, symptomatic aortic stenosis after treatment with one of the two devices.
Patients, treated between September 22, 2014...
Source: Mass Device - February 28, 2019 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Clinical Trials Featured Replacement Heart Valves Boston Scientific Medtronic Source Type: news
Corindus asks FDA for expanded neurosurgery indication for CorPath GRX
Corindus Vascular Robotics (OTC:CVRS) said today that it submitted an application seeking FDA premarket clearance to use its CorPath GRX robotic surgical platform in neurovascular interventions.
The Waltham, Mass.-based company has already received FDA clearance for percutaneous coronary interventions, which it won in 2016, and for peripheral vascular interventions, which it won last year.
“The ability to treat neurovascular disease with CorPath GRX is the first step for physicians to gain critical experience with robotics. Applying the benefits of robotic precision to neurovascular intervention, while building a w...
Source: Mass Device - February 14, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance Robotics Surgical Corindus Vascular Robotics Source Type: news
FDA expands indications for Medtronic ’ s Pipeline Flex embolization device
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its Pipeline Flex embolization device.
The device is now indicated for patients with small or medium, wide-necked brain aneurysms in the territory from the petrous to the terminus of the internal carotid artery, the Fridley, Minn.-based company said.
The Pipeline Flex was previously cleared for the endovascular treatment of adults with large or giant wide-necked intracranial aneurysms from the petrous to the superior hypophyseal segments, Medtronic said.
Clearance came based on data from the 141-patient PREMIER trial of the device, which reported a one-year ...
Source: Mass Device - February 7, 2019 Category: Medical Devices Authors: Fink Densford Tags: Featured Food & Drug Administration (FDA) Regulatory/Compliance Vascular Medtronic Source Type: news
Medtronic touts study data for thoracic aortic stent
Medtronic (NYSE:MDT) said that its thoracic stent graft for the treatment of a potentially deadly blunt-force chest injury performed well five years after implantation, according to a new study.
The Rescue study of the long-term durability, safety, and efficacy of the Medtronic’s Valiant Captivia thoracic stent graft system for blunt thoracic aortic injury (BTAI) was presented at The Society of Thoracic Surgeons annual meeting in San Diego this week. It was the first five-year, industry-issued dataset ever reported for patients with aortic transections undergoing thoracic endovascular aortic repair (TEVAR).
BTAI is...
Source: Mass Device - January 30, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials News Well Research & Development Stent Grafts Medtronic Society of Thoracic Surgeons Source Type: news
InspireMD touts results of ‘one-size-fits-all’ stroke-prevention study
InspireMD’s CGuard embolic prevention stent
A clinical trial of InspireMD’s (NYSE:NSPR) CGuard embolic prevention stent showed that it successfully treated patients whose carotid arteries varied in size, according to the company.
The investigator-initiated trial in Germany used a 10 mm diameter CGuard stent with SmartFit technology across a broad range of carotid artery diameters. Variations in diameters of the common carotid artery (CCA) and the internal carotid artery (ICA), as well as inaccurate x-ray images caused by projection angles, make choosing the correct size choice of a carotid stent challenging, a...
Source: Mass Device - January 28, 2019 Category: Medical Devices Authors: Nancy Crotti Tags: Blog Clinical Trials Implants Neurological News Well Research & Development Stents InspireMD Source Type: news
Terumo ’ s MicroVention wins FDA approval for Web brain aneurysm device
Terumo (OTC:TRUMY;TYO:4543) subsidiary MicroVention said today that it won pre-market approval from the FDA for the Web brain aneurysm device it acquired when it bought Sequent Medical back in 2016.
Aliso Viejo, Calif.-based MicroVention said the PMA for the Web embolic coil covers the treatment of intracranial wide neck bifurcation aneurysms.
“We are proud to offer our latest innovation to the neuroendovascular market in the United States with the introduction of the Web system, achieving the most rigorous standard of FDA approval through the PMA process,” MicroVention president & CEO Richard Cappetta sai...
Source: Mass Device - January 7, 2019 Category: Medical Devices Authors: Brad Perriello Tags: Featured Food & Drug Administration (FDA) Neurological Regulatory/Compliance MicroVention-Terumo Inc. Sequent Medical Source Type: news
Omron launches HeartGuide watch-based wearable BP monitor
Omron Healthcare (TYO:6645) said late last week that it launched its HeartGuide wearable blood pressure monitor, touting it as the world’s first such device.
The HeartGuide is an FDA-cleared, wearable oscillometric blood pressure monitor intended for personal use and styled to function as a wrist watch, the Lake Forest, Ill.-based company said. The device features a cuff in the wrist watch band which inflates to measure systolic and diastolic pressures at a clinical level of accuracy, the company claims.
The newly launched HeartGuide also monitors physical activity including steps taken, distance walked, calories b...
Source: Mass Device - December 27, 2018 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Diagnostics Featured Omron Omron Healthcare Source Type: news
