Tag: sirolimus

MedAlliance SELUTION SLR

First two patients enrolled in PRISTINE study with Selution SLR

MedAlliance has announced enrolment of the first two patients in the PRISTINE registry with Selution sustained limus release (SLR) 018 drug-eluting balloon (DEB) for...
MedAlliance SELUTION SLR

First sirolimus DEB patient enrolled in Japanese SELUTION SLR study

MedAlliance’s partner in Japan, MDK Medical, has enrolled the first patient in the clinical study of its novel sirolimus drug-eluting balloon (DEB), SELUTION SLR,...
MedAlliance SELUTION SLR

First patient enrolled globally in SELUTION SLR study for AV fistulae

MedAlliance has announced enrolment of the first patient in the SAVE (Use of the Selution sirolimus-eluting balloon for dysfunctional AV access treatment indications) study...
interim

LINC 2020: XTOSI study interim findings suggest “highly promising” safety and...

Edward Choke (Singapore) talks to BLearning Peripheral at LINC 2020 (Leipzig Interventional Course; 28–31 January 2020, Leipzig, Germany) about the first-in-man clinical study—XTOSI—which looked at the safety and...

MedAlliance receives CE mark approval for SELUTION SLR sirolimus drug-eluting balloon...

MedAlliance has announced the award of its first CE mark approval: for SELUTION SLR, a novel sirolimus drug-eluting balloon (DEB), for the treatment of...
device designation for its sirolimus DEB

MedAlliance receives third FDA breakthrough device designation for its sirolimus DEB...

MedAlliance, the first drug-eluting balloon (DEB) company in the world to receive US Food and Drug Administration (FDA) breakthrough device designation status for a...

VIVA 2019: SELUTION sirolimus DCB safe and effective through two years

The SELUTION SFA trial met its primary endpoint and demonstrated an late lumen loss of 0.19mm. Furthermore, excellent freedom from clinically driven TLR was...
MagicTouch

Concept Medical granted CE certification for sirolimus-coated MagicTouch group of products

Concept Medical received CE certification for their MagicTouch group of products on 16 October 2019. The CE certified products/brands are as listed below: MagicTouch—PTA (sirolimus-coated...
breakthrough

MagicTouch AVF sirolimus-coated balloon granted FDA breakthrough device designation

Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for MagicTouch AVF, its sirolimus drug-coated balloon (DCB)...
breakthrough

MagicTouch PTA sirolimus coated balloon granted breakthrough device designation by FDA

Concept Medical has been granted breakthrough device designation from the US Food and Drug Administration (FDA) for its MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus...
Virtue sirolimus-eluting balloon

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...

Late-breaking ILLUMENATE data demonstrate three-year safety and efficacy for Stellarex DCB

Three-year results from the ILLUMENATE Pivotal trial and the ILLUMENATE European randomised controlled trial (EU RCT) have been presented in a late-breaking trial session...

Sirolimus has “a much wider” safety window and shows fewer local...

 Paclitaxel kills the cells in the artery wall; sirolimus simply stuns them. So says Peter Gaines (Sheffield, UK) at VLF 2019 while commenting on...