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Total 467 results found since Jan 2013.
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
Penumbra prices $99m offering
Penumbra (NYSE:PEN) said today that it priced a public offering worth nearly $99 million, not including an underwriter’s option worth nearly $15 million.
Alameda, Calif.-based Penumbra makes a line of instruments designed for neurovascular and peripheral vascular procedures, including stroke revascularization, embolization and thrombectomy.
The company said it plans to float 1.3 million shares at $76 apiece. The offering also includes a 30-day over-allotment option of some 195,000 shares that, if exercised in full, would bring the total raise to more than $113.6 million.
Penumbra said it plans to use the proceeds fo...
Source: Mass Device - March 17, 2017 Category: Medical Equipment Authors: Brad Perriello Tags: Catheters Funding Roundup Wall Street Beat Penumbra Inc. Peripheral Artery Disease Stroke 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
AliveCor raises $30m, launches Kardia Pro platform in U.S.
AliveCor said today that it landed $30 million in a series D funding round and that it released its artificial intelligence-enabled Kardia Pro platform in the U.S.
The company’s platform enables doctors to remotely monitor their patients for early signs of atrial fibrillation, a common cardiac arrhythmia.
“Heart disease is the No. 1 cause of death in the United States, claiming more lives than all forms of cancer combined. To manage heart disease and stroke risk, leading cardiologists want to see more than just ECGs from their patients,” CEO Vic Gundotra said in prepared remarks. “Kardia Pro tracks important meas...
Source: Mass Device - March 16, 2017 Category: Medical Equipment Authors: Sarah Faulkner Tags: Cardiovascular Funding Roundup Patient Monitoring Wall Street Beat AliveCor 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
7 wearable medtech companies to see at the Wearable Technology Show
[Image from Unsplash.com]Wearable devices aren’t going anywhere anytime soon in the world of medtech. The Wearable Technology Show 2017 is taking place March 7 and March 8 at the Excel in London, offering a chance to check out some of the latest wearable devices.
Digital health technology, smart textiles and sensors, and augmented reality are just some of the types of wearables exhibited at the Wearable Technology Show this year.
From hearing enhancement technology to a credit-card-sized medical-grade EKG, here are 7 companies that will be exhibiting at the show this week.
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The post 7 wearable medtech compa...
Source: Mass Device - March 7, 2017 Category: Medical Equipment Authors: Danielle Kirsh Tags: Cardiovascular mHealth (Mobile Health) Patient Monitoring 112Motion Alango Technologies AliveCor Aparito BeWell Innovations Cardiomo elderly Hearing Parkinson's disease Stroke vitals Walk With Path wearables 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
FDA panel supports Claret Medical ’ s Sentinel, despite efficacy questions
The FDA’s Circulatory System Devices Panel this week gave its support to de novo clearance for Claret Medical’s Sentinel embolic protection device despite weak efficacy data for the device.
The Santa Rosa, Calif.-based company’s Sentinel device is designed to use a pair of temporary arterial filters during trans catheter aortic valve replacement procedures to trap blood clots before they reach the brain.
Members of the panel said that while current efficacy data on the device was not strong enough to assess its ability to prevent stroke, the device may be worth allowing due to its safety profile and the possibl...
Source: Mass Device - February 24, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. 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
