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Vascular

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

United Therapeutics launches Remunity pump for Remodulin

February 10, 2021 By Sean Whooley

united-therapeutics-deka

United Therapeutics (NSDQ:UTHR) announced today that it launched its Remunity pump for Remodulin in patients with pulmonary arterial hypertension (PAH). Research Triangle Park, N.C.-based United Therapeutics’ Remunity pump initially received FDA clearance in May 2019 for patient filling, adding another 510(k) clearance in February 2020 to enable cassettes to be prefilled with Remodulin by contracted […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: Deka Research and Development, United Therapeutics

Surmodics rises on mixed-bag Q1

February 9, 2021 By Sean Whooley

SurModics

Surmodics (NSDQ:SRDX) shares ticked up today on first-quarter results that were mixed compared to the consensus forecast. The Eden Prairie, Minn.-based company posted losses of $274,000, or -2¢ per share, on sales of $22.3 million for the three months ended Dec. 31, 2020, for a bottom-line slide into the red on a sales decline of -1.4%. […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, MassDevice Earnings Roundup, Vascular, Wall Street Beat Tagged With: Surmodics

Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral

January 26, 2021 By Sean Whooley

SurModics

Surmodics (NSDQ:SRDX) announced data showing that its SurVeil drug-coated balloon is non-inferior to Medtronic’s In.Pact Admiral. Eden Prairie, Minn.-based Surmodics’ 12-month data from the Transcend clinical trial, presented at the Leipzig Interventional Course 2021 virtual event, revealed primary results that found the SurVeil DCB is non-inferior to In.Pact Admiral in both safety and efficacy while delivering […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Vascular Tagged With: Medtronic, Surmodics

Medtech manufacturers must add warning label to drug-eluting PAD devices

June 16, 2020 By Nancy Crotti

UK medtech regulators on Monday announced that manufacturers of paclitaxel-eluting balloons for use in peripheral arteries must add a warning label about the devices’ risks. A meta-analysis published in the Journal of the American Heart Association in 2018 suggested that patients treated with paclitaxel-coated balloons and stents for peripheral artery disease could be at a higher risk for late death compared […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Regulatory/Compliance, Vascular Tagged With: B. Braun Medical, Biosensors International, Biotronik, Boston Scientific, cook medical, FDA, Lutonix, LVD Biotech, Medtronic, Spectranetics, UK Medicines and Healthcare products Regulatory Agency

Study: High- and low-dose drug-coated balloons equally effective in PAD

January 30, 2020 By Nancy Crotti

Medtronic, Boston Scientific

A Boston Scientific (NYSE:BSX) device coated with less of the controversial drug paclitaxel than one made by Medtronic (NYSE:MDT) is just as safe and effective for patients with peripheral artery disease (PAD), according to a study published this week. The prospective, randomized controlled trial compared the lower-dose (2 μg/mm2 of paclitaxel) Boston Scientific Ranger drug-coated […]

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

Orchestra BioMed wins breakthrough nod for Virtue SEB

September 17, 2019 By Sean Whooley

orchestra-biomed-logo

Orchestra BioMed said today that it received breakthrough device designation from the FDA for its Virtue sirolimus-eluting balloon for the treatment of below-the-knee peripheral artery disease. The Virtue SEB is the first and only non-coated below-the-knee sirolimus-eluting angioplasty balloon system to receive a breakthrough nod, Orchestra BioMed said in a release. The New Hope, Pa.-based […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Vascular Tagged With: FDA, orchestrabiomed, Terumo Corp.

Cook Regentec launches blood filtration trial for critical limb ischemia

September 11, 2019 By Nancy Crotti

Cook Medical - updated logo

Cook Medical’s Regentec division today announced the launch of a clinical trial to evaluate its HemaTrate blood filtration system to treat patients with critical limb ischemia (CLI) due to peripheral arterial disease (PAD). Indianapolis-based Cook Regentec said the HemaTrate system is designed to produce an autologous, peripheral blood-derived total nucleated cell (TNC) concentrate for intramuscular […]

Filed Under: Clinical Trials, Featured, Research & Development, Uncategorized, Vascular Tagged With: cook medical, Cook Regentec

Medtronic’s In.Pact AV DCB meets endpoints in trial

September 9, 2019 By Sean Whooley

Medtronic logo updated

Medtronic (NYSE:MDT) said last week that its clinical study comparing the In.Pact AV drug-coated balloon to percutaneous transluminal angioplasty (PTA) met primary safety and effectiveness endpoints. The study pitted the In.Pact AV DCB against PTA in patients with de novo or non-stented restenotic arteriovenous fistulae lesions. Results were presented at the Cardiovascular and Interventional Radiology Society […]

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

FDA wants more study of paclitaxel-eluting devices’ long-term safety

August 8, 2019 By Nancy Crotti

FDA-logo-new

The FDA said yesterday that it wants more long-term safety and effectiveness studies done on paclitaxel-eluting stents and balloons, and urged physicians to carefully consider when to use them. In a letter to healthcare providers, the agency recommended discussing the risks and benefits of the devices with patients and continue “diligent monitoring” of patients who […]

Filed Under: Drug-Device Combinations, Food & Drug Administration (FDA), Regulatory/Compliance, Research & Development, Uncategorized, Vascular Tagged With: FDA

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