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 (SLR) drug-eluting balloon (DEB), Selution...
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...

Sirolimus on the rise but paclitaxel “will probably come back again”

At this year’s Leipzig Interventional Course (LINC 2020; 28–31 January, Leipzig, Germany), William Gray (Main Line Health, Philadelphia, USA) considered the future of drug-coated...

Alvimedica introduces SFA sirolimus-eluting stent

At the Leipzig Interventional Course 2020 (LINC; 28–31 January, Leipzig, Germany), Alvimedica held a Lunch Symopsium in which they introduced a new in-stent treatment...
MedAlliance SELUTION SLR

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...
MedAlliance SELUTION SLR

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...

Patient enrolment completed in MedAlliance PRESTIGE BTK clinical trial

MedAlliance has announced completion of patient enrolment in the PRESTIGE below-the-knee (BTK) clinical trial. The objective of this clinical investigation is to evaluate the...

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...

Sundance sirolimus-coated balloon catheter granted FDA breakthrough device designation

Surmodics has announced that the US Food and Drug Administration (FDA) has designated its Sundance sirolimus-coated balloon catheter as a breakthrough device under the...
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...

Vascular Therapies announce positive preliminary clinical results from its AV fistula...

Vascular Therapies is developing Sirogen, a proprietary sirolimus formulation for intraoperative local, perivascular drug delivery focused on improving vascular access outcomes in patients with...

MagicTouch AVF sirolimus-coated balloon granted breakthrough device designation for use in...

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...

Positive AV fistula outcomes following intraoperative pharmacological intervention using a perivascularly...

Intraoperative perianastomotic delivery of sirolimus is feasible, according to Sriram Iyer (Lenox Hill Hospital, New York, USA). Based on preliminary data from 56 arteriovenous...

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," says Peter Gaines (Sheffield, UK). Gaines commented at the 2019 Vascular Leaders...

US$60 million raised to fund sirolimus-coated balloon investigational trial

Concept Medical Inc. has approached the FDA for an investigational device exemption (IDE) for their sirolimus-coated balloon (DCB). To support this process, they have...

First-in-man study of Med Alliance’s Selution sirolimus-coated balloon completes enrolment

Med Alliance has announced the on-schedule completion of patient enrolment in the first-in-man (FIM) study of Selution, the company’s sirolimus-coated balloon. Fifty patients have...

Initial patients enrolled in first-in-man study of Selution sirolimus-coated balloon

Med Alliance has announced first patient enrolment in the first-in-man study of the Selution novel sirolimus-coated balloon. Patients were enrolled at the Universitaets-Herzzentrum, Bad...