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

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...
MedAlliance SELUTION SLR

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...
February's

Interventional News’ top 10 most popular items of February 2022

The February top 10 features news of the recent Japanese randomised control trial results, which support the use of mechanical thrombectomy in ischaemic stroke...

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...
MedAlliance SELUTION SLR

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...
MedAlliance SELUTION SLR

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...
MedAlliance SELUTION SLR

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 SELUTION SLR

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...
MedAlliance SELUTION SLR

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 (25–29 January, virtual). The objective of...
MedAlliance SELUTION SLR

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...
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...

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...
PRESTIGE

Patient enrolment completed in PRESTIGE below-the-knee clinical trial

Patient enrolment in the PRESTIGE below-the-knee (BTK) clinical trial has been completed. The objective of this clinical investigation is to evaluate the six-month safety...