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Prominent cardiologist calls for a halt to Watchman implants
A prominent cardiologist is calling for a stop to left atrial appendage closure procedures using Boston Scientific‘s (NYSE:BSX) Watchman device, claiming the procedures, which seek to reduce stroke in patients with nonvalvular atrial fibrillation, result in the opposite.
Dr. John Mandrola argues that randomized, controlled trials of the Watchman, designed for LAA closure, showed the device failed to reduce ischemic stroke, despite being designed for just that purpose.
“Yet we look away; or we let advocates distract us with complicated statistics,” Dr. Mandrola wrote in an article on Medscape. “Iâ€...
Source: Mass Device - November 10, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Boston Scientific Source Type: news
Codman Neuro acquires Neuravi
Johnson & Johnson (NYSE:JNJ) business unit Codman Neuro said today it acquired Neuravi and its portfolio of neurovascular therapy technology for an undisclosed amount.
Neuravi produces the EmboTrap and EmboTrap II revascularization platforms designed capture clots and allow blood flow to resume immediately after the clot has been secured in patients who have experienced a stroke.
J&J’s Codman Neuro said that the acquisition, along with its recent Pulsar Vascular buy, demonstrates the company’s “strong commitment to delivering innovative products for stroke therapy,” according to a press ...
Source: Mass Device - April 10, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Mergers & Acquisitions Neurological Codman Neuro Neuravi Limited Source Type: news
Johnson & Johnson hosts launch party for Cerenovus neurovascular biz
Johnson & Johnson (NYSE:JNJ) said today it launched its Cerenovus brand, which combined its Pulsar Vascular and Neuravi acquisitions and its remaining Codman Neuro neurological portfolio.
Cerenovus was launched at the European Society of Minimally Invasive Neurological Therapy’s 9th annual meeting, J&J said.
Johnson & Johnson said that the Cerenovus product portfolio aims to help improve stroke care, with the number of strokes annually projected to rise from 1.1 million in 2000 to 1.5 million by 2025.
“We believe stroke should not be a life sentence. Cerenovus is inspired by our long heritage ...
Source: Mass Device - September 7, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Neurological cerenovus johnsonandjohnson Neuravi Limited Pulsar Vascular Source Type: news
MassDevice.com +5 | The top 5 medtech stories for September 15, 2017
Say hello to MassDevice +5, a bite-sized view of the top five medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 5 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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5. FDA cuts could threaten medtech innovation: Here’s why
The Trump administration’s proposed federal budget could hurt the speed and quality of FDA review times, says a top expert at Musculoskeletal Clinical Regulatory Advise...
Source: Mass Device - September 15, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news
TCT 2017: Medtronic touts 1-year intermediate data for Evolut R TAVR
Medtronic (NYSE:MDT) is touting data from a pair of studies of intermediate-risk patients implanted with its Evolut R replacement heart valve, presented today at the Transcatheter Cardiovascular Therapeutics annual meeting in Denver.
Fridley, Minn.-based Medtronic presented results from its Surtavi trial and Evolut R Forward real-world study of its next-generation transcatheter aortic valve replacement today at TCT.
One-year data from Surtavi, comparing the Evolut R and CoreValve devices with open heart surgery, showed a 7.8% mortality rate for the TAVR arm, compared with 8.5% for the open surgery arm. A sub-group analysi...
Source: Mass Device - October 31, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Medtronic Source Type: news
Cerebrotech wins expanded CE Mark for brain bioimpedance monitor
Brain monitor dev Cerebrotech Medical Systems said today it won expanded CE Mark approval in the European Union for its portable brain bioimpedance monitor with indications for detecting bioimpedance asymmetry associated with stroke.
The certification expands previously won clearance which indicated the device for use in detecting changes to intracranial fluid in patients at risk for edema, the Pleasanton, Calif.-based company said.
“Our ability to quickly assess and respond to strokes is critical to ensuring good outcomes for our patients. Having access to a device that can give us this information rapidly has the p...
Source: Mass Device - November 29, 2017 Category: Medical Devices Authors: Fink Densford Tags: Diagnostics Neurological Regulatory/Compliance Cerebrotech Medical Systems Source Type: news
J & J ’ s Biosense Webster launches WaveCrest study
Johnson & Johnson‘s (NYSE:JNJ) Biosense Webster said today that the first patient has been enrolled in an investigational device exemption trial for its WaveCrest system.
The 1,250-patient study is designed to assess the safety and efficacy of the WaveCrest left atrial appendage occlusion system as a way to reduce the risk of embolic stroke in atrial fibrillation patients.
“The WaveCrest System is designed to enable physicians to close the heart’s LAA, where most stroke-causing blood clots occur,” Dr. Larry Chinitz, who treated the first patient in the trial at New York University Hospital, s...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Sarah Faulkner Tags: Cardiovascular Clinical Trials BioSense Webster Inc. johnsonandjohnson 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
IschemaView wins expanded FDA nod for Rapid neuroimager
Medical imaging dev IschemaView said today that it won expanded FDA clearance for its Rapid neuroimaging platform intended for use in selecting patients likely to benefit from endovascular thrombectomy.
With the clearance, the Menlo Park, Calif.-based company said that its Rapid CT-Perfusion and Rapid MR-Perfusion devices can now be used to aid in selecting acute stroke patients with known occlusions of the internal carotid artery or proximal middle cerebral artery for a clot removal procedure.
IschemaView touted its Rapid system as the only imaging platform approved for selecting stroke patients for clot removal.
“T...
Source: Mass Device - January 15, 2019 Category: Medical Devices Authors: Fink Densford Tags: Food & Drug Administration (FDA) Imaging Neurological Regulatory/Compliance ischemaview 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
UPDATE: Boston Scientific jumps on Watchman approval
Shares of Boston Scientific jump today after the FDA approves its Watchman anti-stroke device.
Investors sent shares of Boston Scientific (NYSE:BSX) up nearly 4% today after the medical device company said the FDA approved its long-delayed Watchman anti-stroke device.
Boston ScientificNews Well, Cardiac Implants, Pre-Market Approval (PMA), Regulatory/Compliance, Stroke, Wall Street Beatread more
Source: Mass Device - March 16, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news
UPDATE: FDA OKs new Sapien 3 valve from Edwards
UPDATED June 18, 2015, with details from Edwards and Leerink Partners.
The FDA said today that it approved Edwards Lifesciences‘s (NYSE:EW) Sapien 3 transcatheter heart valve for inoperable or high-risk patients with a narrowing in the heart’s aortic valve.
The approval was based on a 583-patient clinical study of patients who were at high risk for open heart surgery or who could not undergo the surgery due to excess risk, the federal watchdog said.
“Clinical data showed that the Sapien 3 transcatheter heart valve is superior to the 1st generation Sapien transcatheter heart valve, with significantly l...
Source: Mass Device - June 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) Edwards Lifesciences Source Type: news
Penumbra touts thrombectomy study data
Penumbra said last week that a study of its Ace64 thrombectomy system shows the device to be effective in patients with acute ischemic stroke. The data from the study was presented at the Society of NeuroInterventional Surgery’s annual meeting in San Francisco.
The 117-patient, 6-country study reported a 96% revascularization rate in acute ischemic stroke patients with large vessel occlusions and a 62% revascularization rate in patients with thrombolysis in cerebral infarction, according to Penumbra.
“The multi-center European experience has demonstrated the effectiveness of Ace64. The innovative technology of ...
Source: Mass Device - August 3, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Penumbra Inc. Source Type: news
SentreHeart wins CE Mark for Lariat LAA closure device
SentreHeart said today it won CE Mark approval in the European Union for its Lariat surgical left atrial appendage suture delivery device used for soft tissue closure.
The device is commonly used for the ligation of the LAA as an adjunctive treatment to ablation in patients with persistent atrial fibrillation, the Redwood City, Calif.-based company said.
Closing off the LAA prevents blood clots from forming that could later cause stroke in AF patients.
“The Lariat surgical device solves many of the issues posed by current closure technologies in surgery. Improving the surgeon’s control, reducing operator variabilit...
Source: Mass Device - October 8, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Regulatory/Compliance Surgical SentreHeart Source Type: news
TCT 2015: Medtronic touts CoreValve TAVI real-world registry data
Update: Added data from study of new patient populations
Medtronic (NYSE:MDT) said today it released the 1st real-world registry study of its CoreValve transcatheter aortic valve implant, reporting outcomes in-line with its clinical trials of the device.
The medtech giant also released new data from 3 studies focusing on new patient populations with significant comorbidities today. Data from all of the CoreValve studies was presented at the annual Transcatheter Cardiovascular Therapeutics conference in San Franscisco.
The 6,160-patient Society of Thoracic Surgeons and American College of Cardiology TVT registry study repo...
Source: Mass Device - October 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Medtronic TCT 2015 Source Type: news
