Log in
Login
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 

4-Traders Homepage  >  News

News

Latest NewsCompaniesMarketsEconomy & ForexCommoditiesInterest RatesHot NewsMost Read NewsRecomm.Business LeadersCalendar 
The feature you requested does not exist. However, we suggest the following feature:

QT Vascular : Submits IDE Requesting Permission to Begin Pivotal Trial of Its Drug-Coated Chocolate Balloon in The United States

share with twitter share with LinkedIn share with facebook
share via e-mail
0
05/05/2016 | 06:17pm CEST

By a News Reporter-Staff News Editor at Clinical Trials Week -- QT Vascular Ltd. (the "Company" or "QT Vascular", and together with its subsidiaries, the "Group"), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, announced it has submitted an investigational device exemption ("IDE") for permission to begin the pivotal study of Chocolate Touch™, its drug-coated balloon, in the United States ("US") (see also QT Vascular Ltd.).

Chocolate Touch™ is the drug-coated version of the Company's Chocolate® PTA balloon. Chocolate® PTA features a unique nitinol constraining structure that causes the balloon to open in a controlled uniform fashion, thus reducing acute trauma, dissections, and unplanned stenting compared to conventional PTA balloons(1). To complement these beneficial acute outcomes, the Company has added a proprietary coating of the drug, paclitaxel, to the Chocolate® platform in order to reduce the incidence of repeat procedures. This combination of an atraumatic balloon platform and a proven therapeutic agent is intended to allow patients to be treated without the need for a permanent implant such as a metallic stent.

"The Chocolate Touch™ pivotal study is the first of its kind to randomize against an existing drug coated balloon, the Lutonix device from CR Bard," stated Dr. Mehdi Shishehbor of the Cleveland Clinic, co-Principal Investigator. "This state-of-the-art trial design combined with a next generation device is designed to provide physicians and patients the ability to compare treatment options and their performance."

The Chocolate Touch™ proposed US pivotal study is a prospective randomized study in the United States, Europe, and New Zealand that will evaluate patients with symptomatic, de novo disease in the superficial femoral and popliteal arteries. Patients will be randomized 1:1 to the Lutonix drug-coated balloon. The study will evaluate acute end points such as procedural successes and freedom from bail-out stenting, and long term endpoints such as patency, and target lesion revascularization.

"This IDE submission is the culmination of years of careful product development, bench tests, pre-clinical experiments and clinical studies," stated Dr Eitan Konstantino, PhD, CEO of QT Vascular. "This is a significant step for the Company on our path toward being one of the few players in the United States' rapidly growing market for drug-coated balloons."

Drug-coated PTA balloons represent a new category of device that combines the mechanical dilatation of a balloon catheter with the biological effect of a drug to treat occluded arteries. These devices have been available for several years in Europe and were recently approved in the US. Since their approval in the US, adoption has been increasing and CMS (Centers for Medicare and Medicaid Services) has granted additional reimbursement for these devices. According to some analyst estimates(2), revenues for drug-coated balloons are expected to reach US$1 billion by 2020.

The Company's Chocolate Touch™ received CE mark approval in July 2015. The Company has previously announced strong acute and 6 month outcomes in its feasibility study for Chocolate Touch™, ENDURE, with an incidence of bail-out stenting just 1.4%, a lumen loss of only 0.16mm, per-protocol primary patency of 90% and an incidence of clinically-driven target lesion revascularization of only 1.7%. Commercial launch of Chocolate Touch™ in selected countries that are accepting CE mark is underway. The product is not yet approved for use in the US and the receipt of CE mark does not constitute such approval.

(1. )Chocolate BAR interim results presented by Mustapha (AMP, August 2015)

(2. )Morningstar (July 30, 2015)

Keywords for this news article include: QT Vascular Ltd.

Our reports deliver fact-based news of research and discoveries from around the world. Copyright 2016, NewsRx LLC

(c) 2016 NewsRx LLC, source Health Newsletters

share with twitter share with LinkedIn share with facebook
share via e-mail
0
React to this article
Latest news
Date Title
06:17p QT VASCULAR : Submits IDE Requesting Permission to Begin Pivotal Trial of Its Drug-Coated Chocolate Balloon in The United States
06:17p J SAINSBURY : Sainsbury's stores go green by turning food waste into energy
06:17p FUELCELL ENERGY : Exxon and FuelCell to study capturing carbon emissions
06:17p GENERAL ELECTRIC : Barnes-Jewish Hospital Installs the Industry's First General Purpose Digital SPECT/CT
06:17p PETE OLSON : Cutting off ISIS' energy supply
06:17p DEPARTMENT OF CITIZENSHIP AND IMMIGRATION OF CANAD : Start-up visa continues to grow
06:17p UNIPIXEL : Wins Programs with New Japanese PC OEM Customer
06:17p AK ALROSA PAO : ALROSA Vice President Rinat Gizatulin elected as head of subcommittee at Russia’s Chamber of Commerce and Industry
06:17p CHURCHILL CHINA : Issue of Equity, Transfer out of Treasury and Director Dealings - 05/05/2016
06:16p STRATEGY ANALYTICS : China Smartphone Shipments Decline 5 Percent in Q1 2016
Latest news
Advertisement
Hot News 
QGC SUBMISSION : Senate Select Committee on Unconventional Gas Mining
BANGO : Implements Google Play Direct Carrier Billing In India
FALANX GROUP LIMITED : Acquisition, Placing and issue of Loan Notes
FILTRONIC : New Contract Win
EMPRESARIA : Makes Good Start To 2016 With Net Fee Income Higher
Most Read News
05/04DJAustralia March Trade Deficit Narrows
05/04DJAustralian March Retail Sales Rise
05/04 KANTAR HEALTH : Names Diana Tan General Manager for China, Expanding Expertise in Innovative Patient Insights
05/04 PRODUCER PRICE SURVEY : March 2016
12:10a AUSTRADE AUSTRALIAN TRADE COMMISSION : Outcomes from LNG 18
Most recommended articles
05/03DJUBS Shares Drop As Profit Slumps
12:16p FTSE steadies near one-month low; Centrica slumps
12:14p OIL RIVALS COOPERATE TO SLASH EQUIPMENT COSTS : Shell
12:14pDJFannie Mae to Pay $919 Million Dividend to U.S. as Profit Falls--Update
12:14pDJEUROPE MARKETS : European Stocks Break Four-day Losing Run As Oil Prices Rally