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Cardiovascular

Boston Scientific shares positive drug-coated balloon data

October 27, 2023 By Sean Whooley

Boston Scientific Agent drug-coated balloon DCB

Boston Scientific [WtwhTicker symbol=”BSX”](NYSE: BSX)[/WtwhTicker] announced positive data from a trial of its Agent drug-coated balloon (DCB). The Marlborough, Massachusetts-based company presented its results at the Transcatheter Cardiovascular Therapeutics (TCT) meeting. Data demonstrated statistical superiority for Agent compared to uncoated balloon angioplasty. AGENT IDE evaluated the safety and effectiveness of using a DCB to treat […]

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

Abbott has positive data for Esprit drug-eluting resorbable scaffold

October 25, 2023 By Sean Whooley

Abbott [WtwhTicker symbol=”ABT”](NYSE: ABT)[/WtwhTicker] today announced data supporting its Esprit BTK everolimus-eluting resorbable scaffold system. The company designed Esprit BTK to treat people with chronic limb-threatening ischemia (CLTI), a severe stage of peripheral artery disease (PAD). Abbott said its LIFE-BTK trial met both of its primary safety and effectiveness endpoints. It demonstrated the reduction of […]

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

Cordis acquires drug-eluting balloon maker MedAlliance for up to $1.135B

October 2, 2023 By Sean Whooley

MedAlliance SELUTION SLR

MedAlliance announced today that Cordis acquired it for a total consideration that could reach up to $1.135 billion. The companies initially announced the planned deal in October of last year. Cordis, which develops interventional cardiovascular and endovascular technologies, made a $35 million investment last year. Its upfront closing payment totals $200 million, with achievement milestones […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Mergers & Acquisitions, Vascular Tagged With: cordis, MedAlliance

Advanced NanoTherapies picks up $4M investment for drug-coated balloon development

August 22, 2023 By Sean Whooley

Advanced NanoTherapies Sirplux Duo

Advanced NanoTherapies announced today that it collected a $4 million Series A extension from an undisclosed strategic investor. Los Gatos, California-based Advanced NanoTherapies received the investment from a medical device company. It also announced the successful treatment of the first cohort of study participants in its drug-coated balloon trial. The first-in-human trial evaluates initial short-term […]

Filed Under: Business/Financial News, Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Funding Roundup, Vascular Tagged With: Advanced NanoTherapies

Orchestra BioMed wins FDA IDE for drug-coated balloon study

August 8, 2023 By Sean Whooley

Orchestra BioMed logo

Orchestra BioMed (Nasdaq:OBIO) announced today that the FDA granted investigational device exemption (IDE) for its Virtue SAB. The IDE enables the Virtue ISR-US pivotal study. It evaluates Virtue SAB, a novel AngioInfusion balloon for treating artery disease, in treating patients with coronary ISR. New Hope, Pennslyvania-based Orchestra BioMed designed Virtue SAB to enable the protected […]

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

CardioRenal Systems wins FDA breakthrough nod for RenalGuard Therapy device

January 20, 2023 By Sean Whooley

CardioRenal Systems RenalGuard

CardioRenal Systems announced today that it received FDA breakthrough device designation for its RenalGuard Therapy device. Milford, Massachusetts-based CardioRenal Systems designed the device for preventing acute kidney injury (AKI). It’s for patients at risk for cardiac surgery-associated AKI. RenalGuard protects the kidneys with personalized, active hydration. The system maximizes urine output while balancing hydration. It […]

Filed Under: Cardiovascular, Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: CardioRenal Systems

Surmodics announces regulatory delay for its SurVeil balloon
The FDA noted more information on biocompatibility and labeling is needed.

January 19, 2023 By Danielle Kirsh

SurModics

The FDA has indicated that Surmodics’ Surveil drug-coated balloon premarket approval application is not approvable. According to an FDA letter to the company, Surmodics’ Surveil was not approved due to certain information in the biocompatibility and labeling categories. The governing agency said more information needs to be added by an amendment to Surmodics’ PMA application to […]

Filed Under: Cardiovascular, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Surmodics

FDA approves Medtronic drug-eluting stents for treating bifurcation lesions

September 21, 2022 By Sean Whooley

Medtronic Resolute Onyx drug-eluting stent

Medtronic (NYSE:MDT) announced today that the FDA approved its Onyx drug-eluting stents (DES) for treating certain lesions. Approval covers the treatment of non-left main bifurcation lesions utilizing the provisional bifurcation stenting technique. The technique uses a single stent to treat the bifurcation in percutaneous coronary interventions (PCIs). It applies to the FDA-approved and CE-marked Onyx […]

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

Advanced NanoTherapies wins FDA breakthrough nod for drug-coated balloon

September 19, 2022 By Sean Whooley

Advanced NanoTherapies Sirplux Duo

Advanced NanoTherapies announced today that it received FDA breakthrough device designation for its SirPlux Duo drug-coated balloon (DCB). Los Gatos, California-based Advanced NanoTherapies received the breakthrough nod for the use of the DCB in treating coronary artery disease in vessels less than 3.0mm. The regulatory win comes weeks after two previous breakthrough designations. SirPlux Duo […]

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

Medtronic launches Onyx Frontier drug-eluting stent

August 25, 2022 By Danielle Kirsh

Onyx Frontier Medtronic

Medtronic (NYSE:MDT) launched its newest drug-eluting coronary stent, Onyx Frontier. The Fridley, Minnesota-based company designed the Onyx Frontier drug-eluting stent (DES) to build upon its Resolute Onyx DES. It uses the same stent platform as the Resolute Onyx and has an enhanced delivery system to increase acute performance in interventional coronary artery disease procedures. Get […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Stents, Vascular Tagged With: Medtronic

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