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Real-World Study Confirms Benefit of XARELTO ® (rivaroxaban) for Secondary Prevention of Venous Thromboembolism in Cancer Patients
TITUSVILLE, NJ, December 9, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced observational data from eight years of clinical practice showing that the oral Factor Xa inhibitor XARELTO® (rivaroxaban) is associated with comparable effectiveness and safety to the Factor Xa inhibitor apixaban for the treatment of cancer-associated thromboembolism (CAT) in a broad cohort of patients with various cancer types. Patients with CAT are at a higher risk of venous thromboembolism (VTE), which is the second-leading cause of death in people with cancer.1Data from the Observational Study in Cancer-A...
Source: Johnson and Johnson - December 9, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news

Getting in on the Embolic Protection Action for TAVR
There has been an increase in the need for embolization protection devices as the risk for stroke and other neurological damage from transcatheter aortic valve replacement (TAVR) procedures continues to become more prevalent.   Santa Cruz, CA -based Emboline is looking to enter the embolization protection space, which is set to grow from $406 million this year to $605 million by 2023, according to a report from ResearchandMarkets. The emerging medtech company's contribution to the space would come from its Emboliner Embolic Protection Catheter.  The Emboliner is a cylindrical mesh filter that completely lines the aorta...
Source: MDDI - April 20, 2018 Category: Medical Devices Authors: Omar Ford Tags: Implants Cardiovascular Source Type: news

Emboline raises $10m Series B for TAVR embolism filter
Emboline said today that it pulled in a $10 million Series B round for the namesake embolic protector it’s developing for heart valve replacement procedures. The Emboliner catheter is designed to prevent blood clots from passing into the cerebral vasculature during transcatheter aortic valve replacements. Santa Cruz, Calif.-based Emboline said the round includes $3 million from a consortium led by SV Tech Ventures and Shangbay Capital and $7 million in already-issued convertible notes. The cash is earmarked for Emboline’s SafePass clinical trial, submission for CE Mark approval and initial commercialization, ...
Source: Mass Device - April 19, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Vascular Wall Street Beat Emboline Source Type: news

Mitralign raises $10m
Mitralign, which is looking to commercialize its namesake mitral valve treatment and pursue regulatory nods for its Trialign tricuspid valve device, said it raised nearly $10 million. The $9.8 million funding, of a hoped-for $30.2 million, came from 19 unnamed investors beginning last September, the Tewksbury, Mass.-based company said in a regulatory filing. Mitralign raised a $40 million Series E round in May 2016. The Mitralign and Trialign devices are designed to use wire and catheters to implant polyester anchors within the annulus of the mitral and tricuspid valves. The anchors are then cinched together to reduce v...
Source: Mass Device - February 21, 2018 Category: Medical Devices Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Mitralign Inc. Source Type: news

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

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

Subclinical leaflet thrombosis in surgical and transcatheter bioprosthetic aortic valves: an observational study
The objective of this study was to report the prevalence of subclinical leaflet thrombosis in surgical and transcatheter aortic valves and the effect of novel oral anticoagulants (NOACs) on the subclinical leaflet thrombosis and subsequent valve haemodynamics and clinical outcomes on the basis of two registries of patients who had CT imaging done after TAVR or SAVR. Methods Patients enrolled between Dec 22, 2014, and Jan 18, 2017, in the RESOLVE registry, and between June 2, 2014, and Sept 28, 2016, in the SAVORY registry, had CT imaging done with a dedicated four-dimensional volume-rendered imaging protocol at varying int...
Source: The Lancet - March 18, 2017 Category: Journals (General) Source Type: research

Claret Medical files for FDA clearance for Sentinel cerebral protection device
Claret Medical said today that it filed an application with the FDA seeking 510(k) clearance for its Sentinel cerebral protection system designed for use during transcatheter aortic valve replacements. The Santa Rosa, Calif.-based company’s Sentinel device is designed to capture and remove embolic debris dislodged during TAVR procedures, which can enter cerebral circulation and can potentially lead to strokes. “Our contribution in building significant new science will help the rapidly growing TAVR field embrace the critical role of cerebral protection in all left heart and endovascular procedures. These studi...
Source: Mass Device - September 20, 2016 Category: Medical Equipment Authors: Fink Densford Tags: Food & Drug Administration (FDA) Regulatory/Compliance Replacement Heart Valves Vascular Claret Medical Inc. Stroke Source Type: news

Colibri Heart Valve looks to raise $25m Series C for TAVR device
Colibri Heart Valve is looking to raise a $25 million Series C for the ready-to-use replacement heart valve it’s developing and has already put $1.25 million into its coffers. Broomfield, Colo.-based Colibri is running a 1st-in-human trial of the transcatheter aortic valve replacement it’s developing, a pre-mounted, pre-crimped and pre-packaged device that’s designed to be shipped ready to use, according to its website. Colibri has said that patients enrolled in the study showed no observed stroke, no pacemaker implantations, virtually no paravalvular leak and a high retained average effective orifice ...
Source: Mass Device - March 29, 2016 Category: Medical Equipment Authors: Brad Perriello Tags: Funding Roundup Replacement Heart Valves Wall Street Beat Colibri Heart Valve Source Type: news