Tag: sirolimus

MedAlliance SELUTION SLR

“Excellent” 12-month results from SELUTION SFA trial presented

Twelve-month results from the SELUTION SFA trial have been presented for the first time at the Japan Endovascular Treatment (JET) Conference (26–28 May, Tokyo,...

First US patient is enrolled in MedAlliance sirolimus DEB study

The first US patient has been enrolled in the SELUTION4SFA sirolimus drug-eluting balloon (DEB) study by Arthur Lee (Cardiac & Vascular Institute, Gainesville, USA)....
Surmodics

Surmodics provides regulatory update related to its FDA premarket approval application...

Surmodics recently announced it has received a letter from the US Food and Drug Administration (FDA) related to its premarket approval (PMA) application for...
TOP 10

Interventional News’ top 10 most popular stories in 2022

Interventional News covered a whole range of the specialty's news during 2022, but readers' attention was most piqued by acquisitions (Boston Scientific's of Obsidio...
SIRONA

SIRONA trial enrolment completed

Concept Medical has announced the successful completion of enrolment for the SIRONA randomised controlled trial (RCT) investigating the use of its Magic Touch PTA...

Cordis announces acquisition of MedAlliance

Cordis today announced its acquisition, subject to customary closing conditions including regulatory approvals, of MedAlliance. A press release notes that the agreement includes an...
Surmodics

Six-month SWING trial data show promise for Sundance DCB

Six-month data from the Surmodics SWING first-in-human (FIH) study of the company’s Sundance sirolimus drug-coated balloon (DCB) were shared at the 2022 Amputation Prevention...
Motiv

Preliminary MOTIV BTK outcomes positive for bioresorbable scaffold use in below-the-knee...

Thomas Rand (Klinik Florisdorf, Vienna, Austria) recently presented on the preliminary results to 12 months of the Motiv bioresorbable scaffold (Reva Medical) postmarket trial...
TOP 10

Interventional News’ top 10 most read items of August 2022

Interventional News' popular stories last month included acquisitions by Boston Scientific and Gore, studies of deep vein thrombosis and peripheral arterial disease treatments and,...

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...

SIRONA head-to-head randomised trial achieves 50% enrolment

Concept Medical recently announced that the SIRONA randomised controlled trial (RCT; Head-to-head comparison of sirolimus versus paclitaxel drug-eluting balloon angioplasty in the femoropopliteal artery)...

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...

IMPRESSION trial assessing MagicTouch AVF passes 50% enrolment

Concept Medical has shared the latest update from its IMPRESSION (Sirolimus-coated balloon angioplasty versus plain balloon angioplasty in the treatment of dialysis access dysfunction)...
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...
R3 Vascular

R3 Vascular reports the initiation of its first-in-human clinical study

R3 Vascular has reported the successful initiation of its first-in-human clinical study evaluating the technical and clinical performance of the R3 Vascular Magnitude bioresorbable...
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...
MagicTouch

Concept Medical releases status updates on SIRONA RCT

Concept Medical has released a series of status updates on their head-to-head SIRONA (Sirolimus versus paclitaxel drug-eluting balloon angioplasty in femoropopliteal diseases) randomised controlled...
trerotola misra tan av access dcbs drug coated balloons

More mixed results for DCBs in AV access maintenance as evidence...

Additional randomised controlled data regarding the effectiveness of drug-coated balloons (DCBs) in maintaining arteriovenous (AV) access offers new evidence, but it is freighted with...
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

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...