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 […]
Cook Medical touts paclitaxel-coated stent PAD study results
Cook Medical today touted five-year data from a study into the use of its Zilver PTX paclitaxel-coated stent for peripheral arterial disease (PAD). The study concluded that there was no increase in long-term all-cause mortality due to paclitaxel after treatment using the Zilver PTX stent compared to traditional angioplasty or a bare-metal stent, according to a […]
Medtronic lands reimbursement for MiniMed 670G pump in Germany
Medtronic (NYSE:MDT) said today it has secured reimbursement for its MiniMed 670G insulin pump system from regulators in Germany. The German Federal Association of the Statutory Health Insurances (GKV-SV) granted reimbursement for the smart insulin pump for patients with type 1 diabetes, according to the company. In May, Medtronic released real-world data from more than 8 […]
Satsuma Pharmaceuticals registers $75m IPO
Satsuma Pharmaceuticals has registered an initial public offering, seeking to raise $75 million, according to a regulatory filing. The South San Francisco-based company is working on STS101, a nasal powder version of dihydroergotamine for migraine. It intends to use the money to fund its Phase 3 safety and efficacy clinical trials for STS101, manufacturing costs, […]
Report: Dexcom shares drop in response to ‘headwinds’ comment
Shares in Dexcom (NSDQ:DXCM) dropped nearly 6.8% this morning following comments by a company executive that the company is facing “headwinds” that could hamper third-quarter results, according to a report by SeekingAlpha. EVP and CFO Quentin Blakford told attendees at Morgan Stanley’s Healthcare Conference in New York that comparisons to Q3 2018 results could be […]
Delcath Systems raises another $9.5m
Delcath Systems (OTC:DCTH) has closed on a $9.5 million private placement round, bringing the total amount raised since July to $29.5 million. The Queensbury, N.Y.-based company priced the round at $1,000 per unit, with each unit consisting of a preferred convertible share worth 16,667 common shares, at a 6¢ strike price, and a five-year warrant […]
FDA grants breakthrough nod to Concept Medical for below-the-knee use of MagicTouch DCB
Medtech developer Concept Medical said today it won FDA breakthrough device designation for below-the-knee (BTK) use of its MagicTouch sirolimus drug-coated balloon catheter designed for the treatment of peripheral artery disease. The Tampa, Fla.-based company won the same designation for MagicTouch for the treatment of coronary in-stent restenosis in April. The XTOSI clinical study at Sengkang […]
FDA wants more study of paclitaxel-eluting devices’ long-term safety
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 […]
Omnipod Dash sales drive Insulet Q2 results
Insulet (NSDQ:PODD) reported second-quarter results yesterday that missed the consensus forecast on Wall Street, but raised its outlook for the rest of the year. The Acton, Mass.-based diabetes tech company reported profits of $1.4 million or $0.02 per share, on sales of $177.1 million for the three months ended June 30, 2019, for a bottom-line […]
B. Braun wins breakthrough nod for drug-coated balloon catheter
The FDA has granted B. Braun Interventional Systems breakthrough device designation for the company’s SeQuent Please ReX drug-coated percutaneous transluminal coronary angioplasty (PTCA) balloon catheter for the treatment of coronary in-stent restenosis (ISR). The designation follows 10 years of clinical studies on the SeQuent Please drug-coated PTCA catheters, with data reported in peer-reviewed articles, according to the […]
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