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Total 110 results found since Jan 2013.

Gore Takes on Abbott with New PFO Stroke Indication
W.L. Gore & Associates has received FDA approval to expand the indication of the Gore Cardioform Septal Occluder to reduce the risk of recurrent ischemic stroke in patients. The device treats patients through the closure of patent foramen ovale (PFO). Cardioform’s previous indication was for the closure of atrial septal defects that are up to 17mm in size. Gore’s Structural Heart Leader, Jake Goble said Cardioform has the potential to redefine stroke prevention. Goble began working for Gore in 2007. It was around that time the company began to explore the possibility of having the Cardioform focus on stroke prevent...
Source: MDDI - April 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

An Inflection Point for Stroke Care
In the past six months, stroke care in the United States has taken an epoch-changing turn. Techniques, technologies, and treatment pathways hinted at in earlier trials have become fully vetted and are a new gold standard giving doctors more time to treat stroke patients and help them regain pre-stroke capabilities. Two recent trials, especially, DAWN and DEFUSE 3, have precipitated industry-wide shifts in the way hospitals treat stroke, especially acute ischemic stroke. "I guess the best thing I can say is we have altered our practice here, essentially immediately, based on the results of those studies. I guess that shows ...
Source: MDDI - April 2, 2018 Category: Medical Devices Authors: Greg Goth Tags: Cardiovascular Source Type: news

Medtronic and Viz.ai Look to Improve Stroke Outcomes with New Alliance
A collaboration between Viz.ai and Medtronic could lead to better outcomes for stroke patients. Through the distribution agreement, San Francisco, CA-based Viz.ai would increase the reach of its artificial intelligence solution for stroke. Viz.ai’s solution identifies suspected large vessel occlusion (LVO) strokes and automatically notify specialists. It could lead patients to get treatment by technologies like Dublin-based Medtronic’s Solitaire revascularization device. “By combining AI software with therapy that works, that’s how we can truly improve...
Source: MDDI - July 23, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Software Source Type: news

Abbott ’s Amplatzer Stroke Reduction Data Is Strong at EuroPCR
Abbott Laboratories’ Amplatzer Amulet left atrial appendage (LAA) occlusion device has been shown at one year to reduce stroke by 57% as compared to the predicted stroke risk. The data also showed it was able to make this reduction without the need for lifetime blood thinners.  The Abbott Park IL-based company released the data at EuroPCR, the annual meeting of the European Association of Percutaneous Cardiovascular Interventions in Paris, and simultaneously published in EuroIntervention. More than 1,078 patients suffering from atrial fibrillation (Afib) were in the study with one-year-follow up. “The Amulet is a devi...
Source: MDDI - May 24, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular 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

Abbott Wins Approval for CATALYST Trial for At-Risk Stroke Patients
This study is an extremely important step in assessing the Amplatzer Amulet as an effective non-prescription drug alternative for patients with AFib who are at an increased risk for ischemic stroke." In an email sent to MD+DI, Abbott wrote, “We already have an Amulet IDE trial underway that is intended to support our submission for approval in the U.S. for Amplatzer Amulet. The newly announced CATALYST trial will support our submission for an expanded indication for Amulet as a safe and effective alternative to NOAC drugs for patients with atrial fibrillation and at risk of stroke.” Abbo...
Source: MDDI - February 3, 2020 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Regulatory and Compliance Source Type: news

AI Becoming Prevalent in Identifying Stroke, Head Trauma
Another company is throwing its hat into the ring to use artificial intelligence to help identify bleeds, fractures and other critical abnormalities in head CT scans. San Mateo, CA-based Qure.ai released the results of a clinical validation study confirming its algorithm’s near-radiologist performance on 21, 000 patients and has made a dataset of almost 500 AI-analyzed head CT scans available for download. The results have been published in a research paper on Cornell University's online distribution system for research, arXiv.org. The paper is titled “Development and Validation of Deep Learning Algorithms for Detectio...
Source: MDDI - May 3, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Digital Health Source Type: news

AI-Based Stroke Rehab System Shown to Be as Effective as One-on-One Therapy
The idea that the brain is capable of rewiring after a stroke is not new, but the therapy needed to achieve this is cumbersome at best. “Studies show that neuroplasticity requires hundreds to thousands of hours of repetition of focused, concentrated training to get the brain to have those functional changes,” said David Wu, Motus Nova’s CEO, in an interview with MD+DI. But he explained that those many hours of therapy with a clinician are not always feasible for patients, because of concerns about time and logistics, cost, and sometimes even a lack of motivation. So, Mo...
Source: MDDI - June 1, 2019 Category: Medical Devices Authors: Susan Shepard Tags: Digital Health Source Type: news

Beware of Off-Label Use of Wingspan Stent
Off-label medical device use is a tricky subject and one that has been at the center of many heated debates. It is strictly against the law for manufacturers to promote their products for off-label use, however, physicians have the discretion to use a device in an off-label manner if such use might be beneficial to the patient. Sometimes, however, FDA does try to intervene if the off-label use of a particular device raises a concern about patient safety. Case in point, Stryker's Wingspan Stent System. Approved in 2005 under a Humanitarian Device Exemption, the Wingspan has provoked advoc...
Source: MDDI - April 26, 2019 Category: Medical Devices Authors: Amanda Pedersen Tags: Regulatory and Compliance Source Type: news

A Tale of Two Telehealth Acquisitions
Telemedicine companies are actively looking for ways to open the sector up to broader adoption. Partnerships and acquisitions seem to be the fastest means to that end, as two recent telemedicine deals would suggest. InTouch Health, a Santa Barbara, CA-based telemedicine firm, said it will acquire REACH Health, an Alpharetta, GA-based telemedicine software company.  Shortly after the deal was announced, Boston, MA-based American Well, reported its agreement to acquire Avizia, a prominent player in the acute care telehealth space. Financial terms were not disclosed for either deal. "The telehealth industry is fragmented and...
Source: MDDI - May 2, 2018 Category: Medical Devices Authors: Amanda Pedersen Tags: Digital Health Business Source Type: news

Cerenovus Receives FDA Nod for EMBOTRAP II
Johnson & Johnson’s Cerenovus unit has received an FDA nod to market the EMBOTRAP II Revascularization Device. The device is a next generation stent retriever used to capture and remove life-threatening blood clots from the brain following an ischemic stroke. The EMBOTRAP II Device is designed to rapidly restore blood flow by gripping and retrieving clots within the neurovasculature, with minimal compression, protecting against further complications. The device is indicated for use within eight hours of stroke symptom onset. In the ARISE II study, which was submitted as part of the 510(k) application to FDA, neuroint...
Source: MDDI - May 21, 2018 Category: Medical Devices Authors: Omar Ford Tags: Cardiovascular Source Type: news

Viz.ai Raises $50M in Series B round
Viz.ai’s 2019 has been marked with strong adoption of its artificial intelligence software and securing a distribution agreement with one of medtech’s biggest players. The Tel Aviv, Israel and San Francisco-based company’s latest accomplishment is raising $50 million in a series B round. The financing was led by Greenoaks with participation from Threshold Ventures, CRV along with existing investors GV and Kleiner Perkins. “This [financing] allows us to get to the next stage,” Dr. Chris Mansi, neurosurgeon, co-founder, and CEO, told MD...
Source: MDDI - October 25, 2019 Category: Medical Devices Authors: Omar Ford Tags: Business Source Type: news

Data Boosts Support for Abbott, Gore PFO Closure Tech
Devices designed to lower a patient's stroke risk by surgically closing a hole in the heart known as a patent foramen ovale, have historically had a tough time in clinical trials. Data from three separate studies published in the New England Journal of Medicine could go a long way toward boosting support two market-leading PFO closure devices, but figuring out who should have the procedure and who should not continues to be a gray area for clinicians and patients. Long-term results from the RESPECT trial, which evaluated the Amplatzer device that Abbott acquired when it bought St. Jude Medical, along with new data from G...
Source: MDDI - September 15, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: MD & M Minneapolis R Medical Device Business Source Type: news

Here & #039;s the Secret Behind Boston Scientific & #039;s New DBS Device
Unlike traditional deep brain stimulation (DBS) systems that are built from pacemaker technology, Boston Scientific's Vercise DBS is modeled from cochlear implant technology and the precise stimulation of auditory nerves it uses to replicate hearing. The device is now FDA approved for the treatment of Parkinson's disease symptoms, the company announced this week. "The cochlear implant technology, when you think about it, is really designed and engineered to precisely stimulate the auditory nerves to produce a sense of hearing," Maulik Nanavaty, a senior vice president at Boston Scientific and president of the company's ne...
Source: MDDI - December 12, 2017 Category: Medical Devices Authors: Amanda Pedersen Tags: Implants Source Type: news

Abbott Gains on Medtronic in LVAD Market
Abbott Laboratories said late-breaking clinical trial data from its MOMENTUM 3 clinical study shows its HeartMate 3 Left Ventricular Assist Device (LVAD) has improved survival and lowered rates of stroke and pump thrombosis. The Abbott Park, IL-based company released the data during the American College of Cardiology’s 67th Annual Scientific Sessions this past weekend. Data from MOMENTUM 3 was also published in the New England Journal of Medicine and showed patients with the HeartMate 3 LVAD had a survival rate of 82.8% at two years compared with 76.2% for those with the HeartMate II LVAD. Pump thrombosis rates remained ...
Source: MDDI - March 12, 2018 Category: Medical Devices Authors: Omar Ford Tags: Business Cardiovascular Source Type: news