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MassDevice.com +5 | The top 5 medtech stories for April 11, 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. Get this in your inbox everyday by subscribing to our newsletters.   5. Stimwave wins Australian regulatory nod for Freedom SCS Stimwave Technologies said late last week it won approval from the Australian Therapeutic Goods Administration for its Freedom spinal cord stimulation system, and launched ...
Source: Mass Device - April 11, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news

ISHLT 2017: Medtronic HVAD trial misses primary endpoint, reports lowered stroke rates
Medtronic (NYSE:MDT) said today that results from the Endurance supplemental trial of its HVAD heart pump system did not meet its primary endpoint, but did report  lowered stroke rates compared to standard treatment. The trial aimed to evaluate the use of the HVAD system, which it picked up along with HeartWare last year, as a destination therapy for patients who require a left ventricular assist device and received improved blood pressure management, the Fridley, Minn.-based company said. Data from the study was presented at the 2017 International Society for Heart and Lung Transplantation Scientific Meeting in San Dieg...
Source: Mass Device - April 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiovascular Clinical Trials HeartWare International Inc. Medtronic Source Type: news

Medtronic launches Arctic Front cryoablation PVI study
Medtronic (NYSE:MDT) said today it enrolled the 1st patient in the Stop Persistent AF clinical trial of its Arctic Front Advance cardiac cryoablation catheter. The 225-patient, 12-month trial aims to explore the effectiveness and safety of pulmonary vein isolation-only treatments for patients with persistent atrial fibrillation using the Arctic Front Advance cryoablation catheter, the Fridley, Minn.-based company said. The 1st patient in the trial was treated by Dr. John Harding at Penn.’s Doylestown Hospital, the company said. “Gaining meaningful data from this trial will help further clinicians’ underst...
Source: Mass Device - March 30, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Medtronic Source Type: news

FDA green-lights Aegis Medical trial for Sierra ligation device
This study will confirm the safety of the Sierra device for patient use, and will lay a solid foundation for future efforts to demonstrate that Sierra can prevent stroke in AF patients and eliminate the need to take blood thinners for stroke prevention,” principal investigator Dr. Sheldon Singh of Toronto’s Sunnybrook Health Sciences Centre said in a prepared release. “For many AF patients, anticoagulants are used to reduce the risk of stroke. One of the downsides of these drugs is that they can result in life-threatening bleeding. Aegis has developed a minimally invasive, non-vascular LAA closure device,...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Food & Drug Administration (FDA) Aegis Medical Innovation Source Type: news

Medtronic wins FDA nod for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut Pro transcatheter arortic heart valve replacement designed for treating severe aortic stensosis. The newly cleared, next-gen CoreValve Evolut Pro features an outer wrap to add surface area contact between the valve and the native aortic annulus to increase valve sealing performance, Fridley, Minn.-based Medtronic said. “Medtronic remains committed to working with interventional cardiologists and cardiac surgeons to deliver solutions that address patient needs with the safety and performance profile they expect from Medtronic. We are excited ...
Source: Mass Device - March 22, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 17, 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. Get this in your inbox everyday by subscribing to our newsletters.   5. GlucoMe tackles connected diabetes management with acoustic data transmission The Centers for Disease Control & Prevention predict that by 2050, if current trends continue, 1 in 3 adults in the U.S. will have diabetes. The d...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: News Well Plus 5 Source Type: news

ACC 2017 Roundup: Medtronic ’ s CoreValve as good as surgery in intermediate-risk trial
The team at MassDevice.com and Drug Delivery Business News will be updating this post periodically as news comes out of ACC 2017, the annual American College of Cardiology meeting in Washington March 17-19. Medtronic’s CoreValve as good as surgery in intermediate-risk trial A study comparing surgical valve replacement with transcatheter aortic valve replacement using the CoreValve device made by Medtronic (NYSE:MDT) showed that the TAVR device was as safe as surgery in intermediate-risk patients, according to data presented today at ACC 2017. Two-year data from the 1,657-patient Surtavi study, presented at ACC 2017 a...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves ACC 2017 Medtronic Source Type: news

MassDevice.com +5 | The top 5 medtech stories for March 8, 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. Get this in your inbox everyday by subscribing to our newsletters.   5. Court clears Caldera’s $12.3m transvaginal mesh settlement A California federal judge last week approved a $12.3 million deal to settle a number of insurance claims over injuries allegedly caused by Caldera Medical’s transv...
Source: Mass Device - March 8, 2017 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 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

Keystone Heart, Venus Medtech ink Asian TAVR stroke partnership deal
Keystone Heart and Chinese heart valve maker Venus Medtech said today they inked a partnership deal covering China and other Asian markets. Through the deal, the companies will provide Venus Medtech’s transcatheter aortic valve replacement system along with Keystone’s TriGuard cerebral embolic protection device. TriGuard is a cerebral embolic protection device designed to reduce the amount of embolic material entering blood circulation to the brain during TAVR procedures, by allowing blood to pass through while catching potentially dangerous embolic debris. “Providing brain protection for every TAVR pat...
Source: Mass Device - March 2, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Cardiovascular Catheters Replacement Heart Valves Keystone Heart Venus Medtech Source Type: news

4 Key Insights When Raising Money for Your Medtech Startup: Interview with Bruce Shook, CEO of Intact Vascular
Welcome to the Medsider interview series, a regular feature at MassDevice. All interviews are conducted by Scott Nelson, Founder of Medsider and Group Director for WCG. We hope you enjoy them! Bruce Shook joined Intact Vascular in 2014 as President and CEO. A highly-experienced, medical device executive with more than 30 years of industry experience, Bruce was previously Co-founder, Director, President, and CEO of Neuronetics, which is a privately held medical device company that markets a non-invasive brain stimulation technology for the treatment of depression. Previously, Shook was Co-founder, Director, President, an...
Source: Mass Device - February 27, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Blog medsider Source Type: news

7 medtech stories we missed this week: Feb. 24, 2017
[Photo from unsplash.com]Several companies made distribution deals this week, while others received approval for their products. Here are 7 medtech stories we missed this week but were still worth mentioning. 1. Israel OKs E-Qure’s BST device for chronic wounds E-Qure Corp. announced this week that it received marketing approval for its Bio-electrical Signal Therapy Device (BST Device) from the Israeli Ministry of Health, according to a Feb. 24 news release. BST is an electrotherapeutic method for treating chronic wounds. E-Qure will begin marketing its device in Israel by activating a signed distribution agreement with...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Electronic Medical Records Imaging Mergers & Acquisitions mHealth (Mobile Health) Regulatory/Clearance Align Technology Clarius Mobile Health Corin Group E-Qure Henry Schein Medical Nexstim Skyline Medical Source Type: news

Medtronic touts Solitaire stent retriever data
Medtronic (NYSE:MDT) yesterday touted data presented at the International Stroke Conference on its Solitaire stent retriever from 4 studies. The Solitaire stent retriever uses a micro-sized catheter to access arteries in the brain, restoring blood flow and removing blood clots that cause acute ischemic stroke. The Stratis AIS study evaluated the impact of treatment delays and patient outcomes when patients were treated with the Solitaire stent retriever and intravenous tissue plasminogen activator. Of the 984 enrolled patients, 64% were treated with the device and IV-tPA, while 36% were treated with the stent retriever al...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Clinical Trials Neurological Wall Street Beat Medtronic 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

Boston Scientific touts no deaths, low PVL rates in Lotus TAVR trial
Boston Scientific (NYSE:BSX) this week presented new data from the Respond extension study of its Lotus transcatheter aortic valve replacement with its Depth Guard technology, touting no deaths and low rates of paravalvular regurgitation. Data from the study was presented at the Cardiovascular Research Technologies CRT 2017 annual meeting in Washington D.C. The 50-patient Respond Extension study aimed to assess clinical and device performance outcomes with its Lotus Valve in combination with the Depth Guard technology. The Marlborough, Mass.-based company’s Depth Guard tech is designed to optimize valve deployment by an...
Source: Mass Device - February 21, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific Source Type: news