Tag: sirolimus
“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 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...
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 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...
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...
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...
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 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)...
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...
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...
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...
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...
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 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...
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 drug-eluting balloon (DEB), 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...
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...
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...
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...
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)...
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 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...
