Medtronic (NYSE:MDT) today announced that it has launched its Prevail drug-coated balloon catheter in Europe. The medtech giant designed the Prevail catheter for percutaneous coronary intervention procedures to treat narrowed or blocked coronary arteries in patients with coronary artery disease. Get the full story on our sister site, Medical Tubing + Extrusion.
Vascular
Boston Scientific initiates coronary drug-coated balloon study in U.S.
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 […]
United Therapeutics posts Street-beating Q1
United Therapeutics (NSDQ:UTHR) today announced first-quarter results that came in well ahead of the consensus forecast. The Research Triangle Park, N.C.-based company posted profits of $28.3 million, or 61¢ per share, on sales of $379.1 million for the three months ended March 31, 2021, for a -79.4% bottom-line slide on sales growth of 6.4%. Adjusted […]
Vascular Therapies touts surgical stenosis treatment trial despite missed primary endpoint
Vascular Therapies announced today that a Phase 3 clinical trial of its Sirogen sirolimus formulation showed encouraging outcomes. Cresskill, N.J.-based Vascular Therapies designed its Sirogen proprietary sirolimus formulation for intraoperative local drug delivery to reduce surgical stenosis in blood vessels. The Phase 3 clinical trial evaluated Sirogen in elderly end-stage renal disease patients, according to […]
B. Braun, Infraredx to collaborate on drug-coated balloon catheter IDE study
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 […]
United Therapeutics launches Remunity pump for Remodulin
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 […]
Surmodics rises on mixed-bag Q1
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%. […]
Surmodics’ DCB shown non-inferior to Medtronic’s In.Pact Admiral
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 […]
Medtech manufacturers must add warning label to drug-eluting PAD devices
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 […]
Study: High- and low-dose drug-coated balloons equally effective in PAD
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 […]
