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QT Vascular

QT Vascular expands pivotal trial of Chocolate Touch DCB

January 16, 2019 By Sarah Faulkner

QT Vascular updated logo

QT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation. The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy. The pivotal study of QT Vascular’s […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Pharmaceuticals, Vascular, Wall Street Beat Tagged With: C.R. Bard, QT Vascular

Teleflex to acquire QT Vascular assets, takes option on Chocolate Heart DCB

May 24, 2018 By Fink Densford

Teleflex, QT Vascular

QT Vascular said today it inked a deal to sell its non-drug coated coronary products to Teleflex (NYSE:TFX), including its Chocolate XD and Glider, with an option to purchase its Chocolate Heart drug-coated coronary balloon catheter which is currently under development. Singapore-based QT Vascular has not released any financial details of the agreement, but said that it will […]

Filed Under: Business/Financial News, Drug-Device Combinations, Featured, Vascular Tagged With: QT Vascular, telefle

QT Vascular launches pivotal trial for drug-coated peripheral balloon

July 31, 2017 By Sarah Faulkner

QT Vascular said today that it launched the U.S. pivotal trial for its Chocolate Touch drug-coated peripheral balloon in the hopes of winning FDA approval. The device won CE Mark clearance in September 2015. The trial is slated to compare the safety and effectiveness of the Chocolate Touch balloon with Bard‘s(NYSE:BCR) Lutonix drug-coated balloon catheter. […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Pharmaceuticals, Vascular, Wall Street Beat Tagged With: C.R. Bard, QT Vascular

TriReme Medical touts Chocolate Heart drug-coated balloon data

June 22, 2017 By Sarah Faulkner

QT Vascular subsidiary TriReme Medical touted angiographic data today from a 24-month follow-up of patients treated with its Chocolate Heart drug-coated balloon. The Chocolate Heart device is a paclitaxel-coated version of the company’s Chocolate coronary balloon that is commercially available in the U.S. The combo therapy was designed to reduce the incidence of repeat procedures […]

Filed Under: Cardiovascular, Clinical Trials, Drug-Device Combinations, Featured, Vascular Tagged With: QT Vascular, trirememedical

FDA approves clinical trial for QT Vascular’s Chocolate Touch DCB

September 20, 2016 By Sarah Faulkner

QT Vascular

QT Vascular said today that it won an investigational device exemption from the FDA for a pivotal study of its Chocolate Touch drug-coated balloon. The device won the CE Mark for treating peripheral artery disease in September 2015 and in July it won approval for treating coronary artery disease. The Singapore-based company is slated to […]

Filed Under: Clinical Trials, Drug-Device Combinations, Featured, Food & Drug Administration (FDA) Tagged With: AngioScore Inc., Peripheral Artery Disease, QT Vascular

QT Vascular wins CE Mark for Chocolate Heart DCB

July 7, 2016 By Brad Perriello

QT Vascular said today that it won CE Mark approval in the European Union for its Chocolate Heart drug-coated balloon for treating coronary artery disease. The Chocolate Heart device is a paclitaxel-coated version of the Chocolate balloon that won FDA approval back in June 2014, the Singapore-based company said. “We are delighted with the CE […]

Filed Under: Cardiovascular, Drug-Device Combinations, Regulatory/Compliance Tagged With: QT Vascular

QT Vascular wins CE Mark for drug-coated balloon

September 9, 2015 By Fink Densford

QT Vascular said Monday it won CE Mark approval in the European Union for its Chocolate Touch drug-coated balloon for treating vascular disease. The device is a paclitaxel coated balloon meant to treat occluded arteries and mechanically dilate them with a balloon catheter, the company said. Singapore-based medical company said it expects a commercial launch of […]

Filed Under: Business/Financial News, Drug-Device Combinations Tagged With: QT Vascular

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