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Total 467 results found since Jan 2013.

Widowmaker: Stents as safe as open heart surgery in left main artery disease
A long-term Korean study finds that stenting is as safe as open heart surgery in treating blockages of the left main coronary artery, also know as the widowmaker. A long-term Korean study found stents as safe as open heart surgery in treating blockages of a coronary artery known as the widowmaker, showing that stented patients did not run a significantly higher risk of suffering a heart attack or stroke. American College of Cardiology, Korean Cardiovascular Research FoundationNews Well, Clinical Trials, Drug-Eluting Stentsread more
Source: Mass Device - April 3, 2015 Category: Medical Equipment Authors: Val Kennedy Source Type: news

More good news for stent thrombectomy
Two more clinical studies, sponsored by Medtronic, show the benefit of stent thrombectomy in treating strokes. A pair of clinical trials comparing treatment with anti-stroke drugs and stent thrombectomy with drug therapy alone showed reduced disability in stoke patients, bringing more good news for stent thrombectomy device makers. Medtronic, New England Journal of MedicineNews Well, Clinical Trials, Strokeread more
Source: Mass Device - April 17, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

HRS 2015: Boston Scientific touts cost-saving data for Watchman
Boston Scientific presents data at the Heart Rhythm Society's annual meeting showing that its Watchman anti-stroke device lowers costs compared with the blood thinner warfarin and aspirin. Boston Scientific, HRS 2015News Well, Clinical Trials, Cardiac Implants, Strokeread more
Source: Mass Device - May 14, 2015 Category: Medical Equipment Authors: Brad Perriello Source Type: news

Penumbra wins FDA nod for Ace64 thrombectomy device
Penumbra says it won 510(k) clearance from the FDA for its Ace64 thrombectomy device. Penumbra said today that it has received 510(k) clearance from the FDA for its Ace64 aspiration thrombectomy device, based on data from the Mr. Clean trial and additional randomized controlled stroke trials. Food & Drug Administration (FDA), Penumbra Inc.News Well, 510(k), Regulatory/Compliance, Strokeread more
Source: Mass Device - May 27, 2015 Category: Medical Equipment Authors: Fink Densford Source Type: news

TAVI: Good early data for Keystone Heart’s TriGuard
Data from a trial of Keystone Heart‘s TriGuard anti-stroke device showed a lower rate of neurologic deficits after transcatheter aortic valve implantation, according to research presented last month at EuroPCR 2015 in Paris. The 85-patient Deflect 3 study found that TAVI patients treated with the Israeli company’s TriGuard, which is designed to allow blood to […] The post TAVI: Good early data for Keystone Heart’s TriGuard appeared first on MassDevice.
Source: Mass Device - June 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Neurological Replacement Heart Valves Keystone Heart TAVI Source Type: news

TAVI: Boston Scientific’s Lotus valve tops Medtronic’s CoreValve – study
Data from a study of Boston Scientific‘s (NYSE:BSX) Lotus Valve showed a greater device success rate than Medtronic‘s (NYSE:MDT) CoreValve in high-risk transcatheter aortic valve replacement patients. The single-center, non-randomized study, published this month in the journal JACC: Cardiovascular Interventions, compared outcomes from 50 high-risk TAVI patients treated with the Lotus valve and 50 similar patients treated with Medtronic’s self-expanding CoreValve device. Success rates were higher at 30 days in the Lotus group, at 84%, versus 64% with CoreValve, according to the study.  These results...
Source: Mass Device - June 17, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiovascular Clinical Trials Replacement Heart Valves Boston Scientific JACC: Cardiovascular Interventions medtronic Source Type: news

Climate change a medical emergency, experts say
(Reuters) — The threat to human health from climate change is so great that it could undermine the last 50 years of gains in development and global health, experts warned today. Extreme weather events such as floods and heat waves bring rising risks of infectious diseases, poor nutrition and stress, the specialists said, while polluted cities where people work long hours and have no time or space to walk, cycle or relax are bad for the heart as well as respiratory and mental health. Almost 200 countries have set a 2°C global average temperature rise above pre-industrial times as a ceiling to limit climate change, but s...
Source: Mass Device - June 23, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Business/Financial News Climate change Source Type: news

Biotronik launches Itrevia MRI-safe quad CRT-D in Japan
Biotronik said today that it launched its Itrevia MRI-safe quad cardiac resynchronization therapy defibrillator in Japan, part of a Japanese rollout of new devices for 2015. The device is equipped with home monitoring connectivity, as well as compatibility with up to 1.5 tesla MRI machines, the German medical device giant said. “As a producer of superior medical technologies, it is imperative for us to have a presence in the world’s leading technologies market. It also makes sense that the world’s biggest producer of ProMRI technology should have a strong presence in the country where MRI scanning is the...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Surgical Biotronik Source Type: news

Diabetes: Study finds bariatric surgery beats diet, exercise
A study designed to compare bariatric surgery with lifestyle interventions found that Type II diabetics treated with gastric bypass or banding procedures fared better than patients who watched their diets and exercised. Results from “Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes,” which was funded by Johnson & Johnson (NYSE:JNJ) subsidiaries Ethicon and LifeScan, the Cleveland Clinic and the National Institutes of Health, were published online yesterday in the Journal of the American Medical Assn. The 3-year, 61-patient study randomized obese subjects 1 of 3 arms: Ro...
Source: Mass Device - July 2, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Clinical Trials Weight loss Journal of the American Medical Assn. (JAMA) Source Type: news

FDA warns on potential LVAD issues
The FDA published a safety communication today warning about issues with implantable left ventricular assist devices. The federal watchdog referenced specific issues with both approved implantable LVADs: Thoratec’s HeartMate II and HeartWare’s HVAD system. Adverse events referenced included increased rate of pump thrombosis with the HeartMate II and a high rate of stroke with HeartWare’s HVAD, as well as bleeding complications associated with both devices. The FDA said they have received reports and information from a “variety of sources indicating an increase in the rate of pump thrombosis events i...
Source: Mass Device - August 5, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Assist Devices Cardiac Implants Cardiovascular Food & Drug Administration (FDA) HeartWare International Inc. St. Jude Medical Thoratec Corp. Source Type: news

Study: Edwards’ Sapien and Medtronic’s CoreValve outcomes are similar
A new study published in the Journal of the American College of Cardiology found that patients treated with Edwards Lifesciences‘s (NYSE:EW) and Medtronic‘s (NYSE:MDT) CoreValve showed similar results after 1 year. The 241-patient trial examined high-risk patients with symptomatic severe aortic stenosis 1 year after being treated with either Edwards’s Sapien balloon expanding or Medtronic’ self-expanding transcatheter heart valve. The rates of all-cause death and cardiovascular death were not statistically different between the groups, with a 3-5% difference between the 2 devices, according to the ...
Source: Mass Device - August 11, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Edwards Lifesciences medtronic Source Type: news

MassDevice.com +3 | The top 3 medtech stories for August 10, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.   3. NDC closes Interface Catheter buy, rebrands as Confluent Nitinol Devices & Components said it closed its acquisition of Interface Catheter Solutions and announced it will rebrand the new combined company as Confluent Medical Technologies. Confluent Medical will leverage both NDC and Interf...
Source: Mass Device - August 10, 2015 Category: Medical Equipment Authors: MassDevice Tags: Blog Plus 3 Source Type: news

McGuire to take reins at Second Sight, Greenberg heads board | Personnel Moves
Second Sight Medical‘s (NSDQ:EYES) newly appointed CEO Will McGuire is set to take the reins starting August 18, the company said. Announced in June, former CEO Dr. Robert Greenberg will become chairman of the board at Second Sight, replacing Alfred Mann who will become chairman emeritus, according to the Sylmar, Calif.-based ‘bionic eye’-developing company. “Will brings an immense depth of experience in the life sciences industry that will advance Second Sight’s commercialization of the Argus II retinal prosthesis. After a thorough search process, management and the board of directors are con...
Source: Mass Device - August 13, 2015 Category: Medical Equipment Authors: Fink Densford Tags: Business/Financial News Invuity Monteris Medical Personnel Moves Second Sight Medical Products Inc. Volcano Corp. Source Type: news

MassDevice.com +3 | The top 3 medtech stories for August 17, 2015
Say hello to MassDevice +3, a bite-sized view of the top three medtech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 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.   3. CooperSurgical pays $47m for IVF screener Reprogenetics Cooper Cos. CooperSurgical subsidiary acquired in-vitro fertilization screening company Reprogenetics for nearly $47 million. Livingston, N.J.-based Reprogenetics offers pre-implantation genetic screening and diagnosis for in vitro fertil...
Source: Mass Device - August 17, 2015 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 3 Source Type: news

Nipro to acquire Infraredx
Nipro (TYO: 8086) said today that it plans to acquire Infraredx and its cardiovascular imaging device for an undisclosed amount. Burlington, Mass.-based Infraredx makes an imaging system that combines intravascular ultrasound and near-infrared spectroscopy to provide images of the interior of coronary blood vessels. The company says the device is designed to detect lipid-core-containing plaque, which it says is implicated in higher risk for heart attack or stroke. In 2013 Nipro put down a $25 million equity investment in Infraredx, which earlier this year withdrew an initial public offering it had hoped would raise $56...
Source: Mass Device - September 11, 2015 Category: Medical Equipment Authors: Brad Perriello Tags: Cardiovascular Imaging Mergers & Acquisitions InfraReDx Inc. Nipro Source Type: news