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Source: Mass Device
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Total 467 results found since Jan 2013.
Pivotal trial pits St. Jude Medical ’ s Amplatzer Amulet anti-stroke device against Boston Scientific ’ s Watchman
St. Jude Medical (NYSE:STJ) said today that it launched a U.S. pivotal trial for its Amplatzer Amulet cardiac implant, which is designed to reduce the risk of stroke in patients with atrial fibrillation.
The Amplatzer Amulet device is designed to occlude the left atrial appendage to prevent the formation of blood clots that could lead to a stroke. The FDA approved a similar device made by Boston Scientific (NYSE:BSX), the Watchman implant, in March 2015; St. Jude’s 1,600-patient IDE trial will compare the Amplatzer Amulet to the Watchman in patients with non-ventricular arrhythmias.
The primary safety endpoint is ...
Source: Mass Device - September 1, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiac Implants Cardiovascular Clinical Trials Wall Street Beat Boston Scientific St. Jude Medical Source Type: news
Silk Road touts low stroke rate in 2 studies of Enroute TCAR system
Silk Road Medical yesterday released data from 2 studies of its Enroute transcarotid neuroprotection and stent system, including 1-year data from a pivotal trial of the device and an interim analysis of a post-approval study of the Enroute.
Data from the studies was presented last month at the 44th annual Veith Symposium in New York.
The Sunnyvale, Calif.-based company touts the Enroute system and stent as the 1st and only devices currently approved for transcarotid artery revascularization procedures by the FDA.
Silk Road presented data from the Roadster 1 pivotal trial of the TCAR system, which examined the use of ...
Source: Mass Device - December 13, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Clinical Trials Vascular Silk Road Medical Inc. Source Type: news
Penumbra: Stroke study shows aspiration system equal to stent retrievers
Penumbra (NYSE:PEN) touted data from the Aster trial evaluating its aspiration system compared to a stent retriever as a first-line thrombectomy approach for acute ischemic stroke.
The data showed that the company’s direct aspiration, first-pass technique (Adapt) compared favorably with a stent retriever – 85.4% of patients treated with Penumbra’s aspiration system met the study’s revascularization primary endpoint, compared to 83.1% of their counterparts treated with stent retrievers.
“The Aster study provides evidence that starting with Penumbra aspiration first as part of the Adapt techniqu...
Source: Mass Device - February 22, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Vascular Wall Street Beat Penumbra Inc. 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
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
Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s (NYSE:BSX) Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman to be more cost-effective than its counterparts.
Watchman is a catheter-delivered cardiac implant designed to close off the left atrial appendage, to prevent blood clots from forming there that could later cause a stroke.
The study, published online in the Journal of the American College of Cardiology, showed that the Watchman device was cost-effective at 7 years at a cost of $42,994 per quality-adjust...
Source: Mass Device - December 15, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Wall Street Beat Cardiovascular Cardiac Implants Clinical Trials Boston Scientific Reimbursement Source Type: news
Irregular heartbeat may be tied to more than just stroke risk
(Reuters) – Atrial fibrillation, a type of irregular heartbeat that’s already linked to an increased risk of stroke, may also be tied to higher risk of heart attack, heart failure, kidney disease and sudden death, according to a new research review.
“It was particularly noteworthy that the relative and absolute risk increase for heart failure was the highest among all outcomes examined, even higher than the risk of stroke, said lead author Ayodele Odutayo, a doctoral candidate at the University of Oxford in the U.K.
In atrial fibrillation, the upper chambers of the heart flutter or beat irregularly. Sometimes...
Source: Mass Device - September 8, 2016 Category: Medical Equipment Authors: MassDevice Tags: Cardiovascular American Heart Assn. Source Type: news
Stryker halts enrollment early in Trevo study on high probability of success
Stryker (NYSE:SYK) said today that it’s putting an early stop to enrollment in a clinical trial of its Trevo anti-stroke device after a review board decided there’s a high probability of success for the study.
Kalamazoo, Mich.-based Stryker paid $135 million for Concentric Medical and its Trevo clot retriever back in 2011. The device is designed to remove the blood clots that cause ischemic stroke. Stryker said it’s halting enrollment in the 500-patient Dawn trial after signing on just 200 patients after a scheduled review by the study’s independent Data Safety Monitoring Board.
The Dawn trial is c...
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Vascular Stroke Stryker Source Type: news
Boston Scientific touts 1-year stroke reduction results in Watchman non-valvular AF trial
Boston Scientific (NYSE:BSX) today released 1-year results from the Ewolution registry study of its Watchman left atrial appendage closure device, touting a high implant success rate and stroke reduction in patients with non-valvular atrial fibrillation patients.
Data was presented today at the Heart Rhythm Society’s 39th Annual Scientific Sessions in Chicago.
“We are pleased to see that these ‘real-world’ results reinforce the positive outcomes observed in our clinical trial program, despite the registry patients being older and sicker than those enrolled in our previous trials,” rhythm man...
Source: Mass Device - May 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Boston Scientific Source Type: news
Why innovation isn ’t the key for treating stroke
Stacy Pugh, VP and general manager of Medtronic’s neurovascular unit
Technology and innovation are not the most important things we can do for stroke, according to Stacey Pugh, VP and general manager of the neurovascular unit at Medtronic.
The most important thing that could happen for stroke is passing proper legislation about taking patients in emergency situations to comprehensive stroke centers for proper treatment, Pugh explained during her keynote discussion at DeviceTalks West last month.
Technology has changed, but systems of care have not.
“The most important thing we can do today in stroke unfortunately isnâ...
Source: Mass Device - January 3, 2018 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Neurological DeviceTalks West MedTech Medtronic Source Type: news
FDA clears Medtronic ’ s Riptide clot aspiration device
Medtronic (NYSE:MDT)Â said today that it won 510(k) clearance from the FDA for its Riptide clot aspiration device for treating ischemic stroke.
The Riptide device is designed to retrieve blood clots via the Arc catheter to restore blood flow to the brain. The clearance covers patients with acute ischemic stroke secondary to intracranial large vessel occlusive disease within eight hours of first symptoms, including patients who can’t take or failed off of anti-clotting drugs. Medtronic called the Riptide design “a foundational platform” for other aspiration catheters it’s developing. The Fridley, M...
Source: Mass Device - January 16, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Neurological Medtronic Stroke Source Type: news
Stryker touts AHA, ASA updated guidelines based on Dawn thrombectomy trial results
Stryker (NYSE:SYK) said last week that the American Heart Association and American Stroke Association updated guidelines on ischemic stroke based on evidence from the company-sponsored Dawn trial of its Trevo thrombectomy device.
The new recommendations shift the treatment window from six to 16 hours and state that treatment could be a reasonable course of action for up to 24 hours after a stroke, the Kalamazoo, Mich.-based company said.
“We are excited to see that the hard work and results from the Dawn trial are being embraced by the AHA. My colleagues and I are looking forward to the opportunity to improve the l...
Source: Mass Device - January 29, 2018 Category: Medical Devices Authors: Fink Densford Tags: Clinical Trials Neurological Vascular American Heart Assn. American Stroke Assn. Stryker Source Type: news
Japan approves iSchemaView ’ s Rapid stroke imaging device
iSchemaView today announced that it received registration approval in Japan for its Rapid imaging platform.
The company received registration approval through the Japanese Pharmaceutical Affairs Law and through a third party review by the Japanese Assn. for the Advancement of Medical Equipment for the Rapid imaging platform.
Rapid is designed to give physicians a fast, fully automated and easy-to-interpret imaging system that can help doctors make clinical decisions about stroke.
“Stroke remains the fourth most common cause of death in Japan, and as the population ages, stroke is likely to become an increasing health...
Source: Mass Device - July 8, 2019 Category: Medical Devices Authors: Danielle Kirsh Tags: Cardiovascular Hospital Care Imaging ischemaview Source Type: news
Study: Afib doubles stroke risk after surgery
Surgical patients who experience atrial fibrillation may see a doubled stroke risk in the months following their procedure, according to a new study published in JAMA.
Results from a new study suggest that atrial fibrillation (AF) may pose a significant threat to patients undergoing surgery, especially those having non-cardiac procedures.
In an analysis of more than 1.7 million patients, researchers found that perioperative AF was associated with twice the risk of stroke in patients who had non-cardiac surgery. Patients who underwent a cardiac procedure saw a 30% increase in their stroke risk.
Journal of the A...
Source: Mass Device - August 13, 2014 Category: Medical Equipment Authors: Arezu Sarvestani Source Type: news
FDA panel backs St. Jude’s Amplatzer stroke device in 15-1 vote
An FDA panel Tuesday voted 15-1 in support of St. Jude Medical‘s (NYSE:STJ) Amplatzer cardiac implant for treating patent foramen ovale, according to the Minneapolis Star Tribune.
The Amplatzer PFO device is a nitinol and polyester mesh “double disc” that’s designed to close a naturally occurring hole in the heart that poses the risk of thrombosis and stroke.
The panel found in favor of the device, saying that a long-running study of it showed a “reasonable assurance” that it was safe for use, according to the paper.
In a closer vote, the same panel ruled 11-5 that the device’s benefits o...
Source: Mass Device - May 26, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Food & Drug Administration (FDA) St. Jude Medical Source Type: news
