Tag: MedAlliance
First US patient enrolled in Selution SLR IDE peripheral study
The first US patient has been enrolled in the US Food and Drug Administration (FDA) SELUTION4BTK (below-the-knee) clinical trial evaluating Selution SLR, MedAlliance's novel...
Selution SLR receives second FDA IDE approval
Selution SLR, MedAlliance's sirolimus-eluting balloon, has received conditional US Food and Drug Administration (FDA) investigational device exemption (IDE) approval to initiate its pivotal clinical...
First patient enrolled in SELUTION SLR IDE BTK study
The first patient has been enrolled in the US Food and Drug Administration (FDA) investigational device exemption (IDE) below-the-knee (BTK) SELUTION4BTK clinical trial involving...
FDA grants IDE approval for Selution SLR drug-eluting balloon
MedAlliance’s Selution SLR drug-eluting balloon (DEB) has received investigational device exemption (IDE) approval from the US Food and Drug Administration, making it the first...
New sirolimus data provide encouragement despite “potentially disappointing” efficacy results
The results of a small-scale pilot study from Asia have indicated “potentially disappointing” results with a novel drug-eluting balloon in treating dysfunctional arteriovenous access...
Vascular News’ top 10 most popular stories of February 2022
February's top 10 includes a consensus statement from the Society for Vascular Surgery (SVS) and the Enhanced Recovery after Surgery (ERAS) Society on perioperative...
MedAlliance acquires Japanese partner MDK Medical
MedAlliance has acquired its partner MDK Medical, a Japanese vascular specialist company. MDK Medical has previously worked closely with MedAlliance in developing Japanese clinical...
Eighteen-month PRESTIGE BTK data presented at VIVA 2021
Eighteen-month results from the PRESTIGE below-the-knee (BTK) study were presented as a late-breaking clinical trial at Vascular Interventional Advances (VIVA) 2021 (5–7 October, Las Vegas, USA). The...
Japanese Selution SLR study completes enrolment
MedAlliance, with its Japanese partner MDK Medical, has completed enrolment in the clinical study of its novel sirolimus drug-eluting balloon (DEB), Selution SLR, for...
PRISTINE registry with Selution SLR sirolimus drug-eluting balloon completes enrolment
MedAlliance has announced completion of patient enrolment in the PRISTINE clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of...
MedAlliance raises over US$50 million to roll out Selution SLR and...
MedAlliance recently announced that it has raised over US$50 million in equity funding. The new investor is Trustar Capital (formerly known as CITIC Capital...
LINC 2021: 12-month BTK data with MedAlliance’s SELUTION SLR presented as...
Twelve-month results from the PRESTIGE below-the-knee (BTK) study have been presented as a late-breaking trial at LINC 2021 (The Leipzig Interventional Course; 25–29 January,...
ISABELLA trial for the treatment of failing AV fistulas in haemodialysis...
MedAlliance has announced completion of patient enrolment in the ISABELLA clinical trial with the Selution SLR 018 drug-eluting balloon (DEB) for the treatment of...
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...
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...
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...
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 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...
