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Cardiovascular

Boston Scientific initiates coronary drug-coated balloon study in U.S.

May 12, 2021 By Danielle Kirsh

Boston Scientific AGENT DCB

Boston Scientific (NYSE:BSX) this week launched its Agent IDE trial for its Agent drug-coated balloon. The U.S. prospective, randomized clinical trial will evaluate the safety and effectiveness of a drug-coated balloon (DCB) in patients with coronary in-stent restenosis in lesions up to 26 mm in length in a coronary artery 2.0 mm to 4.0 mm in […]

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

Medtronic touts 2-year study results for In.Pact AV drug-coated balloon

April 20, 2021 By Sean Whooley

Medtronic logo updated

Medtronic (NYSE:MDT) today touted safety and effectiveness results from a 24-month study of its In.Pact AV drug-coated balloon. Fridley, Minn.-based Medtronic said in a news release that the data demonstrated that the In.Pact AV DCB is the first and only DCB to show sustained and superior effectiveness through two years compared to standard percutaneous transluminal […]

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

B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study

March 31, 2021 By Sean Whooley

B. Braun Interventional Systems Infraredx

B. Braun Interventional Systems (BIS) announced today that it is collaborating with Infraredx on a trial for the B. Braun SeQuent Please ReX. Bethlehem, Pa.-based BIS, a B. Braun affiliate, and Infraredx, a Nipro company, will work together to accelerate the FDA investigational device exemption (IDE) clinical trial for the SeQuent Please ReX drug-coated PTCA […]

Filed Under: Business/Financial News, Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: B. Braun Interventional Systems, Infraredx

FDA produces list of ‘essential’ devices, drugs for health, military emergencies

November 2, 2020 By Nancy Crotti

FDA-logo-new

The FDA has released a list of essential medical devices, medicines and “medical countermeasures” that the Trump administration ordered the agency to buy domestically to fight the novel coronavirus and future health and military crises. Devices on the list include diagnostic testing kits and supplies for rapid test development and processing, personal protective equipment, devices […]

Filed Under: Cardiovascular, Drug-Device Combinations, Hospital Care, Patient Monitoring, Pharmaceuticals, Respiratory Tagged With: Donald Trump, FDA

Abbott touts Xience DES study results

October 15, 2020 By Nancy Crotti

A pair of studies of Abbott’s Xience drug-eluting stent showed no difference between shorter courses of treatment with dual antiplatelet therapy (DAPT) compared with 12 months of DAPT following implantation of the XIENCE drug-eluting stent (DES) in patients who are at a high risk of bleeding. Abbott presented the late-breaking data today at TCT Connect, the […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Implants, Stents Tagged With: abbott, TCT 2020

Pandemic forces Proteus into bankruptcy

June 16, 2020 By Nancy Crotti

Proteus Digital Health updated logo

Proteus Digital Health has filed for Chapter 11 bankruptcy protection, noting that its efforts to raise money or sell the company fell victim to the COVID-19 pandemic. The Redwood City, Calif.-based company missed a $100 million funding target in December. Once valued at $1.5 billion, Proteus previously raised $420 million from investors including Novartis Venture Fund […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Pharmaceuticals Tagged With: Otsuka Pharmaceutical, Proteus Digital Health, Robert Bosch North America, Romaco North America, Xcelience

InCarda Therapeutics raises $35 million

November 8, 2019 By Sean Whooley

InCarda Therapeutics

InCarda Therapeutics — which is developing an inhaled paroxysmal atrial fibrillation drug — filed an SEC Form D confirming the sale of more than $35 million in equity. The Newark, Calif.–based drug-device combo company sold nearly $35.3 million since the first sale of the offering occurred on Oct. 20, 2017, according to yesterday’s filing. Get the full […]

Filed Under: Business/Financial News, Cardiovascular, Drug-Device Combinations, Featured, Funding Roundup Tagged With: incardatherapeutics

China approves Biotronik’s Orsiro drug-eluting stent

October 30, 2019 By Brad Perriello

Biotronik's Orsiro

Biotronik said today that China’s National Medical Products Administration approved its Orsiro drug-eluting stent. Orsiro is a cobalt-chromium stent that elutes the drug sirolimus via the Berlin-based company’s Biolute bioabsorbable polymer coating. Biotronik said it plans to have Orsiro on the Chinese market “in the coming months.” “Orsiro will be a valuable addition to our […]

Filed Under: Cardiovascular, Featured, Regulatory/Compliance, Stents Tagged With: Biotronik

BD to shutter Minnesota Lutonix plant, layoffs ahead for 53

October 10, 2019 By Brad Perriello

Becton Dickinson (NYSE:BDX) is planning to close a Minnesota plant that makes its Lutonix drug-coated balloon next year, as the company looks to consolidate its peripheral intervention business. The decision means layoffs for 53 of the New Hope, Minn., site’s 85 workers; the remaining 32 employees will either move to roles at BD’s Tempe, Ariz., location […]

Filed Under: Cardiovascular, Drug-Device Combinations, Featured Tagged With: Becton Dickinson, Peripheral Artery Disease

BioCardia wins CE Mark renewal for Helix, Morph catheters

October 9, 2019 By Sean Whooley

BioCardia

BioCardia (OTC:BCDA) said yesterday that it won CE Mark renewal for its Helix biotherapeutic delivery catheter and Morph universal deflectable guide catheter for delivery of biotherapeutics to the heart. With the renewed CE Mark, BioCardia said it can continue supporting partners outside the U.S. and move forward with commercial sales of the Helix and Morph systems […]

Filed Under: Cardiovascular, Featured, Regenerative Medicine, Regulatory/Compliance Tagged With: BioCardia

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