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FDA Approves Expanded Peripheral Artery Disease (PAD) Indication for XARELTO ® (rivaroxaban) Plus Aspirin to Include Patients After Lower-Extremity Revascularization (LER) Due to Symptomatic PAD
RARITAN, N.J., August 24, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded peripheral artery disease (PAD) indication for the XARELTO® (rivaroxaban) vascular dose (2.5 mg twice daily plus aspirin 100 mg once daily) to include patients following recent lower-extremity revascularization (LER) due to symptomatic PAD. The approval is based on data from the Phase 3 VOYAGER PAD study. With this approval, XARELTO® is the first and only therapy indicated to help reduce the risks of major cardiovascular (CV) events in p...
Source: Johnson and Johnson - August 24, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news

Keystone Heart looks to launch 3rd-gen TriGuard trials in 2017
Keystone Heart  said yesterday it plans to launch a clinical trial of a 3rd-generation TriGuard cerebral embolic protection device by the end of the year. The Israel-based company said the new device, dubbed the TriGuard 3, will offer technological improvements over previous versions of the device, and that it has accelerated the development program of the device. Keystone Heart’s TriGuard devices are designed to protect the brain from emboli during transcatheter aortic valve replacement and other heart procedures to reduce stroke risk and brain damage. The TriGuard 3 is designed to be anatomy independent and for a ...
Source: Mass Device - August 2, 2017 Category: Medical Devices Authors: Fink Densford Tags: Blood Management Clinical Trials Neurological Research & Development Keystone Heart Source Type: news

CytoSorbents touts Refresh trial study data
CytoSorbents (OTC:CTSO) today presented results from the Refresh trial of its CytoSorb blood purification technology, touting that the trial met its safety goals and that treatment reduced toxic inflammatory mediators during complex heart surgery. Data was presented at the American Association for Thoracic Surgery’s centennial conference in Boston this week. The Monmouth Junction, N.J.-based company’s CytoSorb is an extracorporeal cytokine filter, made up of biocompatible, porous polymer beads that use pore capture and surface adsorption to remove toxic substances from the blood and other bodily fluids. The pr...
Source: Mass Device - May 5, 2017 Category: Medical Equipment Authors: Fink Densford Tags: Blood Management Clinical Trials CytoSorbents Corp. 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

MassDevice.com +5 | The top 5 medtech stories for June 15, 2016
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. Biotronik wins CE Mark for Magmaris bioresorbable scaffold Biotronik said today it won CE Mark for its Magmaris magnesium bioresorbable scaffold designed to treat coronary artery disease. Data from the Biosolve-II trial of the ...
Source: Mass Device - June 15, 2016 Category: Medical Equipment Authors: MassDevice Tags: News Well Plus 5 Source Type: news