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Enrolment completed for MASTER DAPT trial

DAPT
A significant milestone has been reached for a landmark study into the use of short duration dual anti-platelet therapy (DAPT) in high-bleeding-risk (HBR) patients...

ADAPT tissue is “going to be a game-changer” regarding durability in...

ADAPT
Michael Reardon (Houston, USA) talks to BLearning Cardio about the ADAPT tissue technology (Admedus), and the increasing importance of durability as TAVI moves to younger and...

Positive NICE recommendation for Xarelto to prevent atherothrombotic events in CAD...

The National Institute for Health and Care Excellence (NICE) has published the final appraisal determination (FAD) recommending the use of Xarelto (rivaroxaban) by the...

Virtue sirolimus-eluting balloon set for commercial release as Terumo and Orchestra...

Orchestra BioMed and Terumo have formed a global strategic partnership for the development and commercialisation of Virtue sirolimus-eluting balloon (SEB) in the percutaneous coronary...

Scott Gottlieb resigns as head of US FDA

The commissioner of the US Food and Drug Administration (FDA), Scott Gottlieb, has unexpectedly resigned after serving just shy of two years in the...

CRT 2019: Peregrine catheter demonstrated 100% procedural success in post-market clinical...

The Peregrine system infusion catheter (Ablative Solutions) has demonstrated 100% procedural success in the Peregrine post-market clinical trial, new data presented during a late-breaking...

US government shutdown disrupting FDA work

shutdown
The US government shutdown means the country’s Food and Drug Administration (FDA) cannot accept new user fees, which means the agency cannot accept new...

Unique therapeutic approach to treating uncontrolled hypertension receives US$77 million financing

Ablative Solutions has announced the first close of its US$77 million Series D funding round. The round was led by new investor Glide Healthcare,...

FDA releases final rule on acceptance of data from clinical investigations...

The Food and Drug Administration (FDA) has today issued the final rule on “human subject protection; acceptance of data from clinical investigations for medical...