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Source: Mass Device
Condition: Heart Valve Disease

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Total 52 results found since Jan 2013.

Claret Medical raises $21m to support Sentinel system
Claret Medical has raised $21.2 million in a new round of equity financing, according to an SEC filing posted last week. In a press release posted today, the company said that it raised $14.5 million in a Series C round led by Lightstone Ventures and joined by Easton Capital, HealthCor Partners, Incept and Sante Ventures. Proceeds are slated to support market access program, next-gen R&D and expanding commercialization to support its Sentinel cerebral protection system. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medic...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

Medtronic launches pivotal trial of Intrepid TMVR system
Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 patients with severe, symptomatic mitral valve regurgitation into 2 cohorts with a primary endpoint of composite of all-cause mortality, all-stroke, reoperation or reintervention and cardiovascular hospitalization at 1 year. Secondary endpoints in t...
Source: Mass Device - October 23, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Catheters Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Edwards Lifesciences has ‘ key events ’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark by the end of the year, with plans for a U.S. introduction in late 2018. For the Ultra, they’ve added a taller skirt to the Sapien 3 design to improve TAVR outcomes, according to the company. Edwards has incorporated the taller skirt initially with sizes 20, 23 and 26 mm. A...
Source: Mass Device - September 25, 2017 Category: Medical Devices Authors: Chris Newmarker Tags: Business/Financial News Cardiac Assist Devices Cardiac Implants Cardiovascular Catheters Clinical Trials Edwards Lifesciences tavr Source Type: news

Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including all-cause mortality and all stroke at 30 days and clinical performance including valve hemodynamics and paravalvular regurgitation. “We look forward to replicating the excellent clinical outcomes demonstrated by the Evolut Pro valve in a...
Source: Mass Device - September 21, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiac Implants Cardiovascular Clinical Trials Replacement Heart Valves Medtronic Source Type: news

Claret Medical touts Sentinel data in TAVR study
Claret Medical today released results from a study of its Sentinel cerebral protection system, touting reduced early occurrence of stroke associated with transcatheter aortic valve replacement procedures and lowered mortality rates. The study of the device was recently published in the Journal of the American College of Cardiology: Cardiovascular Interventions, the Santa Rosa, Calif.-based company said. The Sentinel embolic protection device is designed to trap blood clots and prevent stroke during heart valve replacement procedures, which Claret Medical touts as the 1st and only FDA-cleared device to do so. “In pat...
Source: Mass Device - September 18, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Clinical Trials Neurological Claret Medical Inc. Source Type: news

Medtronic wins CE Mark for CoreValve Evolut Pro
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its CoreValve Evolut Pro transcatheter aortic heart valve, indicated for the treatment of severe aortic stenosis for symptomatic patients at intermediate, high or extreme risk for open heart surgery The 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. “We are excited to introduce the next evolution of our Evolut TAVI platform to provide physicians in Europe with a comprehensive portfolio to ...
Source: Mass Device - July 31, 2017 Category: Medical Devices Authors: Fink Densford Tags: Cardiovascular Catheters Regulatory/Compliance Replacement Heart Valves Medtronic Source Type: news

Claret Medical raises $11m
Claret Medical has raised $11.2 million in a new round of equity financing, according to an SEC filing posted this week. Money in the round came from 34 unnamed investors, according to the SEC filing, with the 1st sale dated on June 22. Claret Medical is still looking to raise an additional $6.5 million in the round, according to the SEC filing. The company has not yet stated how it intends to use funds raised in the round. The Santa Rosa, Calif.-based company produces the Sentinel embolic protection device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel device uses a...
Source: Mass Device - July 17, 2017 Category: Medical Devices Authors: Fink Densford Tags: Business/Financial News Claret Medical Inc. Source Type: news

FDA clears Medtronic ’ s CoreValve Evolut TAVR in intermediate risk patients
Medtronic (NYSE:MDT) said today it won expanded FDA approval for its CoreValve Evolut transcather aortic valve replacement platform, now indicated for patients with symptomatic severe aortic stenosis who are at an intermediate risk for open heart surgery. The Fridley, Minn.-based company said that patients at intermediate risk for open-heart surgery have a mortality risk of greater than or equal to 3% at 30 days following the procedure. “Patients at intermediate risk for open-heart surgery account for a large portion of the severe aortic stenosis population. We are delighted to take the self-expanding CoreValve Evo...
Source: Mass Device - July 10, 2017 Category: Medical Devices 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 June 12, 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. MassDevice Q&A: Claret Medical’s Azin Parhizgar on trying to make TAVR safer Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

MassDevice Q & A: Claret Medical ’ s Azin Parhizgar on trying to make TAVR safer
Cerebral protection developer Claret Medical recently won FDA de novo clearance for its Sentinel device designed to trap blood clots and prevent stroke during heart valve replacement procedures. The Sentinel uses a pair of filters, 1 in the brachiocephalic artery another in the left common carotid artery, to trap debris released during transcatheter aortic valve replacement that could cause a cerebral embolism. The device has seen a rough road to approval, however, after missing the primary efficacy endpoint in its pivotal trial. Despite that, the device saw nearly unanimous support from an FDA advisory panel and was c...
Source: Mass Device - June 12, 2017 Category: Medical Devices Authors: Fink Densford Tags: Neurological Surgical Vascular Claret Medical Inc. Source Type: news

MassDevice.com +5 | The top 5 medtech stories for June 5, 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. SentreHeart enters pivotal phase after hitting Lariat study milestone SentreHeart can launch the 2nd, pivotal phase in the Amaze study of its Lariat device, after hitting the mark in the 1st, 100-patient stage. Like the Watchma...
Source: Mass Device - June 5, 2017 Category: Medical Devices Authors: MassDevice Tags: News Well Plus 5 Source Type: news

EuroPCR 2017 Roundup: Boston Scientific ’ s Lotus beats Medtronic ’ s CoreValve in head-to-head study
Boston Scientific (NYSE:BSX) said its Lotus replacement heart valve beat the competing CoreValve device made by Medtronic (NYSE:MDT) in a head-to-head trial. Data from the Reprise III study, billed as the 1st head-to-head pivotal trial comparing transcatheter aortic valve replacements, were released today at the annual EuroPCR meeting in Paris. The 912-patient study compared Lotus with the CoreValve and CoreValve Evolut devices in high- and extreme-risk patients. The primary efficacy endpoint was the composite rate of death, disabling stroke and moderate or greater paravalvular leakage at 1 year; the primary safety endp...
Source: Mass Device - May 16, 2017 Category: Medical Devices Authors: Brad Perriello Tags: Clinical Trials Replacement Heart Valves Wall Street Beat Boston Scientific Edwards Lifesciences europcr2017 Medtronic 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

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

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