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Vascular

TriSalus Life Sciences launches new infusion system

June 4, 2025 By Sean Whooley

Trisalus pressure enabled drug delivery (PEDD) system

TriSalus Life Sciences (Nasdaq:TLSI) announced today that it launched its new TriNav FLX infusion system. TriNav FLX features enhanced trackability and significantly expands the company’s existing TriNav portfolio of products. It offers interventional radiologists more options to select the right product for the right patient, TriSalus said in a news release. According to TriSalus, the […]

Filed Under: Business/Financial News, Drug-Device Combinations, Oncology, Vascular Tagged With: trisaluslifesciences

Medtronic earns expanded CE mark for Prevail paclitaxel-coated balloon

May 22, 2025 By Sean Whooley

Medtronic Prevail drug-coated balloon

Medtronic announced today that it received CE mark for several expanded indications for its Prevail balloon catheter. The expanded indications for the paclitaxel-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter (or drug-coated balloon/DCB) cover the treatment of coronary artery disease (CAD). According to the medtech giant, Prevail now has the broadest range of CE mark […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Regulatory/Compliance, Vascular Tagged With: Medtronic

Cordis launches 10,000-patient registry for drug-eluting balloon

May 19, 2025 By Sean Whooley

Cordis today announced the initiation of a global registry to track real-world outcomes for the Selution SLR drug-eluting balloon (DEB). Miami Lakes, Florida-based Cordis expects the SELUTION Global Coronary Registry to enroll up to 10,000 patients worldwide. It says that would make it one of the largest coronary DEB registries to date. Investigators plan to […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Vascular Tagged With: cordis

Orchestra BioMed wins FDA IDE for sirolimus-angioballoon

April 29, 2025 By Sean Whooley

Orchestra BioMed logo

Orchestra BioMed (Nasdaq:OBIO) announced today that it received FDA investigational device exemption (IDE) for its Virtue drug-coated balloon. It marks the second major regulatory milestone for Orchestra BioMed in just a week. The company last week picked up FDA breakthrough device designation for its atrioventricular interval modulation (AVIM) therapy. FDA IDE enables the company to […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: orchestrabiomed

Cordis shares positive study results from multiple drug-eluting balloon studies

April 25, 2025 By Sean Whooley

Cordis Selution SLR drug-eluting balloon

Cordis announced new data from two major peripheral studies evaluating its Selution SLR drug-eluting balloon. The Miami Lakes, Florida-based company presented 12-month results from the SUCCESS PTA study at the Charing Cross Symposium in London. It then shared SELUTION SFA Japan three-year results today at the Japan Endovascular Treatment Conference in Osaka. According to Cordis, the studies […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Vascular Tagged With: cordis

Data backs Boston Scientific drug-eluting stent

April 23, 2025 By Sean Whooley

Boston Scientific Eluvia drug-eluting vascular stent system (1)

Boston Scientific today shared study data supporting the use of its Eluvia drug-eluting stent for treating PAD. The company shared multiple new clinical data sets at Charing Cross 2025 in London today. Findings reinforced the growing body of evidence supporting the Eluvia stent for treating peripheral artery disease (PAD) — particularly in the superficial femoral […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Implants, Stents, Vascular Tagged With: Boston Scientific

R3 Vascular reports first patient treated in next-gen drug-eluting scaffold study

April 22, 2025 By Sean Whooley

R3 Vascular Logo (1)

R3 Vascular announced today that a doctor treated the first patient in the ELITE-BTK pivotal trial of its drug-eluting bioresorbable scaffold. Dr. Brian DeRubertis of New York-Presbyterian and Weill Cornell Medicine treated the first patient. The trial evaluates the company’s next-generation Magnitude drug-eluting bioresorbable scaffold for below-the-knee peripheral arterial disease (PAD). Mountain View, California-based R3 […]

Filed Under: Clinical Trials, Drug-Device Combinations, Implants, Stents, Vascular Tagged With: R3 Vascular

Data supports Medtronic Prevail paclitaxel-coated balloon

March 10, 2025 By Sean Whooley

Medtronic Prevail drug-coated balloon

Medtronic (NYSE: MDT) announced results from a registry highlighting the effectiveness of the Prevail drug-coated balloon (DCB). Dr. Sacharias von Koch of the dept. of cardiology and clinical sciences at Lund University, Skåne University Hospital in Sweden presented findings from the Swedish Coronary Angiography and Angioplasty Registry (SCAAR) at Cardiovascular Research Technologies (CRT) 2025 in […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Vascular Tagged With: Medtronic

Abbott reports sustained benefits with Esprit drug-eluting stent

November 4, 2024 By Sean Whooley

Abbott Esprit BTK

Abbott (NYSE:ABT) today announced data demonstrating the long-term effectiveness of its Esprit BTK drug-eluting stent. The everolimus-eluting resorbable scaffold system treats chronic limb-threatening ischemia (CLTI) below the knee (BTK). Abbott designed it to keep arteries open and deliver everolimus to support vessel healing prior to completely dissolving. The first-of-its-kind stent provides support to the vessel […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Implants, Stents, Vascular Tagged With: abbott

R3 Vascular wins FDA IDE for drug-eluting scaffold

November 4, 2024 By Sean Whooley

R3 Vascular Logo

R3 Vascular announced today that the FDA granted investigational device exemption (IDE) to evaluate its Magnitude drug-eluting bioresorbable scaffold. Mountain View, California-based R3 Vascular designed Magnitude for treating below-the-knee (BTK) peripheral arterial disease (PAD). With the FDA granting IDE, it can now initiate the ELITE-BTK pivotal trial for the next-generation bioresorbable scaffold. R3 Vascular makes […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Regulatory/Compliance, Stents, Vascular Tagged With: FDA, R3 Vascular

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