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Cardiovascular

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

PhysIQ, InCarda Therapeutics to collaborate on AFib treatment tech

August 24, 2022 By Sean Whooley

PhysIQ InCarda Therapeutics

PhysIQ announced today that it entered into a strategic collaboration with InCarda Therapeutics. Newark, California-based InCarda Therapeutics develops first-of-their-kind inhaled therapies for treating cardiovascular diseases. Get the full story at our sister site, MassDevice.

Filed Under: Business/Financial News, Cardiovascular, Clinical Trials, Drug-Device Combinations, Pharmaceuticals Tagged With: incardatherapeutics, PhysIQ

Advanced NanoTherapies closes $7.2M Series A for drug-coated balloon

June 28, 2022 By Sean Whooley

Advanced NanoTherapies Sirplux Duo

Advanced NanoTherapies announced today that it closed an oversubscribed Series A equity financing round. Los Gatos, California-based Advanced NanoTherapies, which develops the SirPlux Duo drug-coated balloon (DCB) for treating de novo coronary artery disease (CAD) lesions, has now raised $12.5 million in total since September 2020. The company said in a news release that the […]

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

First patient enrolled in MedAlliance’s drug-eluting balloon trial

June 8, 2022 By Sean Whooley

MedAlliance SELUTION SLR

MedAlliance announced today that the first patient was enrolled in a trial of its Selution SLR sirolimus-eluting balloon. Last month, the company received FDA investigational device exemption (IDE) for the Selution SLR drug-eluting balloon, which it designed to provide a controlled sustained drug release, similar to a drug-eluting stent. The FDA IDE BTK (below-the-knee) Selution4BTK […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Food & Drug Administration (FDA), Vascular Tagged With: MedAlliance

FDA approves Medtronic’s In.Pact 018 drug-coated balloon catheter

May 31, 2022 By Sean Whooley

Medtronic In.Pact 018 drug-coated balloon catheter

Medtronic (NYSE:MDT) announced that it received FDA approval for its In.Pact 018 paclitaxel-coated balloon catheter. Fridley, Minnesota-based Medtronic’s In.Pact 018 paclitaxel-coated percutaneous transluminal angioplasty (PTA) balloon catheter, a drug-coated balloon product, received an indication for the interventional treatment of peripheral arterial disease (PAD) in the superficial femoral and popliteal arteries. According to a news release, […]

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

FDA grants IDE for MedAlliance’s sirolimus-eluting balloon

May 26, 2022 By Sean Whooley

MedAlliance SELUTION SLR

MedAlliance announced today that it received FDA investigational device exemption (IDE) for its Selution SLR drug-eluting balloon. Geneva, Switzerland-based MedAlliance designed its Selution SLR (sustained limus release) novel sirolimus-eluting balloon to provide a controlled sustained drug release, similar to a drug-eluting stent. Selution SLR features unique micro-reservoirs made of biodegradable polymer intermixed with sirolimus. The […]

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

Medtronic’s Resolute Onyx drug-eluting stent demonstrates strong safety, efficacy

May 18, 2022 By Sean Whooley

Medtronic Resolute Onyx drug-eluting stent

Data presented today at the EuroPCR 2022 event supported the use of the Medtronic (NYSE:MDT) Resolute Onyx drug-eluting stent. University of Padua Medical School Head of Interventional Cardiology Dr. Giuseppe Tarantini presented late-breaking clinical trial results from the investigator-initiated, Medtronic-funded ROLEX (Revascularization Of LEft Main With Resolute onyX) registry. ROLEX, the largest real-world, multicenter prospective […]

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

FDA approves Medtronic’s Onyx Frontier drug-eluting coronary stent

May 13, 2022 By Sean Whooley

Medtronic logo updated

Medtronic (NYSE:MDT) announced today that it received FDA approval for its Onyx Frontier drug-eluting stent (DES). Onyx Frontier, the latest iteration of Medtronic’s Resolute DES family, was designed to leverage the same stent platform as Resolute with an enhanced delivery system for improving deliverability and increasing acute performance, even in the most challenging of cases. […]

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

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