– The ENDURE Trial to assess efficacy of the novel Drug Coated Chocolate® PTA (Chocolate® Touch)
– Chocolate® Touch combines Chocolate’s advantages of minimising dissections and bail-out stenting with the long-term benefits of drug coating
– Reflects progression of Group’s new product growth strategy
SINGAPORE, Sept. 16, 2014 /PRNewswire/ — Catalist-listed QT Vascular Ltd. ("QT Vascular" or together with its subsidiaries, "the Group"), a developer and manufacturer of minimally invasive medical devices for the treatment of vascular diseases, is pleased to announce that the Group has enrolled the first European patients in the ENDURE Trial in Germany. Multiple patients have already been enrolled in this study with Dr. Andrew Holden, at Auckland City Hospital, in Auckland, New Zealand.
ENDURE is a single-arm core-lab adjudicated multi-center clinical trial conducted at top centers in Europe and New Zealand. ENDURE is designed to evaluate the efficacy of Chocolate® Touch at 30 days, 3 months, 6 months, and 12 months. Clinical assessment will include amputation free survival and Rutherford Grade change while core lab measurements will include late lumen loss, patency and target lesion revascularization.
Chocolate® Touch is a novel drug-coated peripheral balloon that combines the acute benefits of the Chocolate® PTA Balloon Catheter with the potential long-term benefits of a paclitaxel-based coating. The Chocolate® platform represents a breakthrough in PTA balloon catheters. Used for the treatment of patients with peripheral arterial disease, it was designed to provide predictable, uniform, less traumatic dilatation and has demonstrated a very low rate of dissections and bail-out stenting(1). Paclitaxel is an anti-proliferative drug that has been shown to be efficacious in the prevention of re-narrowing of the artery over time. In addition to the benefits of the underlying Chocolate Platform, Chocolate® Touch is different from other Drug Coated Balloons as it does not require pre-dilatation (pre treatment with another balloon) and has a larger contact surface for drug transfer.
In the first European patient treated at the prestigious Department of Angiology at Universitats — Herzzentrum Freiburg, Bad Krozingen, Germany, a 6.0x40mm Chocolate® Touch was used to successfully dilate a sub-total occlusion of the superficial femoral artery. "Chocolate’s mechanism of action minimizes vessel trauma and therefore reduces the chances of a dissection. Now coupled with a drug it could provide an option for patients to leave the hospital without a permanent implant, " stated Professor Thomas Zeller, head, Department of Angiology.
QT Vascular previously announced on 24 July 2014, that it has applied for CE marking approval ("CE Mark") with respect to the Chocolate® Touch. The CE Mark approval, which is not expected this year, will allow for marketing of the product in the European Union. This will allow QT Vascular to capitalise on the positive demand for medical devices in Europe and the world. Chocolate® Touch will be the latest addition to the Group’s product pipeline. Prior to this, the Group has announced on 5 June 2014 that its wholly owned US subsidiary, TriReme Medical LLC, received notification from the United States Food and Drug Administration (FDA) of 510(K) clearance to market the Chocolate® Percutaneous Transluminal Coronary Angioplasty Balloon Catheter ("Chocolate PTCA") in the United States, for the treatment of blocked arteries for coronary vascular diseases. Other products in the pipeline include the Silk PTA balloon catheter ("Silk PTA"), a version of Chocolate® PTA that is made for intervention in longer lesions. The Silk PTA is currently at the design feasibility stage, with CE Mark submission targeted for the first quarter of 2015.
Dr. Eitan Konstantino, the Group’s Chief Executive Officer, commented, "We are very excited to expand the ENDURE trial in Europe and expect the enrolment to be faster with additional world class sites joining the study. It is very satisfying to see patients leaving the hospital without having to live with metal left in their leg for the rest of their life. I believe that this is where the field is trending and this is consistent with our vision. Chocolate® Touch represents a key milestone towards the commercialization of our second generation drug-coated balloons and will keep us competitive in the medical device market for peripheral artery diseases."
About Peripheral Artery Disease
Peripheral artery disease (PAD) is caused by the build-up of fatty substances that collect and adhere to the linings of the arteries, in a process known as atherosclerosis. The build-up causes the internal lining of the artery to thicken, narrowing the artery and limiting blood flow to vital tissues and organs. Commonly affected arteries include those located in the legs, arms, neck and kidneys. The vast majority of patients with PAD also have significant concomitant coronary artery disease (CAD) and a high proportion of morbidity and mortality in these patients is related to myocardial infarction, ischemic stroke or cardiovascular death. PAD is estimated to affect 202 million people worldwide.
About QT Vascular Ltd.
QT Vascular Ltd. (QT Vascular) is an emerging leader in the development and commercialization of next generation minimally invasive products for the treatment of complex vascular disease. The Company works closely with leading physicians and scientists from around the world to create differentiated devices that improve procedural and clinical outcomes. QT Vascular is based in Singapore with a US subsidiary, TriReme Medical LLC, in Pleasanton, California. The Company was listed on the Catalist Board of the Singapore Exchange Securities Trading Limited on 29 April 2014.
For more information, please refer to: http://www.qtvascular.com/
(1) Das T for Mustapha J. Chocolate® Bar, Leipzig Interventional Course, 28-31 January, 2014.
(2) "Comparison of global estimates of prevalence and risk factors for peripheral artery disease in 2000 and 2010: a systematic review and analysis." 19 Oct 2013. The Lancet.
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