Newly presented study findings provide reassurance that performance of Abbott’s fully absorbable coronary stent is equivalent to its metallic forebeer at one year.
Cardio
CLEAN-TAVI Trial Results Could See Embolic Protection Become Standard in TAVR
The fact that Claret Medical’s Cerebral Protection system is not yet approved for use in U.S. TAVR procedures looks like an anachronism following study results that point to a high risk procedure and a solution that works.
CE Mark and First US Implant for Medtronic’s Re-Sheathable CoreValve
Medtronic has gained CE Mark approval for the 23 mm CoreValve® Evolut™ R TAVI System and has seen the device’s first implantation in its U.S. study.
Biosensors Polymer/Carrier-Free Drug Stent U.S. Study Starts
A drug coated stent that doesn’t rely on polymeric coatings or a carrier for the drug sounds like a compelling offering. Biosensors will be hoping so as it commences its IDE Feasibility study.
Claret’s CLEAN-TAVI Cerebral Protection Study Sees Patient Enrollment Completed
Claret Medical™, Inc. says the CLEAN-TAVI clinical trial is the first randomised, controlled trial to investigate the importance of cerebral protection during TAVI procedures.
New Study Says VNS Therapy Improves Heart Function In Chronic Heart Failure Patients
A newly presented study shows so-called Autonomic Regulation Therapy (ART) in patients with moderate to severe chronic heart failure and impaired heart function improves the heart’s ability to pump blood, and reduces HF-associated symptoms.
Study Confirms Fractional Flow Reserve Measurement Drives NSTEMI Treatment Strategy
Newly presented data says that using FFR measurement technology changed the course of treatment for more than one fifth of patients suffering non-ST segment elevation myocardial infarction (NSTEMI) heart attacks.
Vagus Nerve Stimulation Study Misses Primary Efficacy Endpoint, But QOL Improved
It’s good news/bad news for Boston Scientific’s Vagus Nerve Stimulation plans as a heart failure therapy. While efficacy endpoints suggested no outcome improvement, patients in the treatment group of the sham controlled study reported quality of life improvement.
Comparative Study Supports St. Jude Quadripolar Leads vs Bipolar
St. Jude claims its Quadripolar pacing system set the standard and a newly presented study is a strong addition to the more than 100 publications supporting the argument.
FDA 510(k) Clearance for CardiacAssist’s PROTEK Duo™ Veno-Venous Cannula
Newly cleared PROTEK Duo™ veno-venous cannula is intended for use as a single cannula for both venous drainage and reinfusion of blood via an internal jugular vein during extracorporeal life support procedures.
FDA Clears CorMatrix® CanGaroo™ ECM® Envelope for Cardiac Implantables
Cormatrix’s aptly named CanGaroo envelope (or pouch) offers a marsupialised approach to cardiac device implantation.
FDA Approval for Medtronic Viva® Cardiac Resynchronization Therapy-Pacemaker
CE marked earlier in the year, Medtronic’s Viva CRT-P system will now be available for US patients following its newly announced FDA approval.
New Money Will Get Claret’s Sentinel™ Stroke Protection Device Through Study
It’s full steam ahead for Claret Medical as it announces Series B financing that will take it a long way down the road to US FDA approval, assuming its pivotal study goes to plan.
CE Mark for New Size of Direct Flow Transcatheter Valve Plus No Use of Contrast Media
This is big news for Direct Flow as it needed that 23mm option to open up a new patient cohort. The avoidance of contrast media is big for the company too.
Study Shows Remote Monitoring Reduces All-Cause Mortality by 50%
It might seem obvious that the heightened level of care provided by remote monitoring of cardiovascular conditions would result in only good things for patients. A new study, published in The Lancet, confirms it.
Boston Scientific and ASAHI INTECC Join Forces on FFR Wire Project
Sounds like a plan. Combine the offerings of one of the Cardiovascular big boys with wire forming company’s expertise and FFR technology is likely to benefit.