SINGAPORE, May 21, 2015 /PRNewswire/ --
Highlights:
QT Vascular Ltd., together with its subsidiaries ("QT Vascular" or the "Group"), a global company engaged in the design, assembly and distribution of advanced therapeutic solutions for the minimally invasive treatment of vascular disease, today announced it has enrolled the first 11 patients in its First-In-Human (FIH) study of its novel Chocolate Touch™ PTCA (Coronary Drug Coated Chocolate®) in the Dominican Republic.
This study initiation represents achievement of key milestone ahead of time. Working closely with local and US physicians, QT Vascular has embarked on a potentially revolutionary study to evaluate the clinical utility of the Chocolate Touch™ PTCA for the treatment of de novo coronary lesions. If successful, this study would provide initial evidence of a new and unique device that could be able to treat the most common coronary disease in a way that minimizes the placement of stents in at least some lesion subsets. Stenting is currently the most commonly used treatment in coronary interventions, but it is a permanent implant that requires expensive long-term dual anti-platelet therapy and is associated with small but significant risks of fracture (1) and late-thrombosis (2)(3). The initial procedural outcomes with Chocolate Touch™ PTCA were successful in all 11 patients and importantly, no stent placement was required. There were also no cases with abrupt closure and no significant dissections were observed.
"I am pleased with the initial acute angiographic results of the Chocolate Touch™ PTCA; they look closer to a stent than a balloon. I have not observed any sub-acute occlusion in these patients which is one of the major risks with conventional balloons," stated Dr. Jihad Mustapha of Metro Health Hospital, Wyoming, Michigan who performed some of the first cases.
Chocolate Touch™ PTCA is based on the unique Chocolate® balloon platform. By reducing acute trauma, Chocolate® was able to reduce severe dissections and thus reduce the need for unplanned stenting in the peripheral arteries when compared to conventional balloons (4). With the addition of the proven anti-proliferative drug, paclitaxel, Chocolate Touch™ PTCA offers the potential to achieve improved acute outcomes that will hold up over time due to paclitaxel's ability to reduce the body's response that may lead to the need for repeat interventions.
"I am pleased to offer to my patient this drug-coated balloon therapy that does not require a stent," stated Dr. Carlos Garcia Lithgow of CECANOT Hospital in Santo Domingo, Dominican Republic. "In my country, the post-stent drug regimen is very expensive and many patients do not comply due to the high cost."
"We have accelerated projects that we believe add strategic value to QT Vascular," stated Eitan Konstantino, PhD, Chief Executive Officer of QT Vascular. "I am thrilled that the team has achieved this important milestone several months earlier than planned. We are looking forward to design and execute the clinical program required for both regulatory approvals and market acceptance."
"The unique combination of low trauma and drug coating makes Chocolate® a promising treatment option. If the data show a low angiographic late loss, there is clearly a place for this device in the future interventional toolbox," said world renowned Cardiologist, Professor Martin B. Leon, Director, Center for Interventional Vascular Therapy, Columbia University Medical Center / New York-Presbyterian Hospital.
While stents have been studied and used extensively for many years, it is desirable to minimize the use of permanent implants in the body. This approach has led to the development and increasing adoption of newer technologies such as bio-vascular scaffolds and drug-coated balloons. Chocolate Touch™ provides a new category consistent with how the market is trending towards less invasive therapies.
| (1) |
Andrew T.L. Ong, et al., Late Angiographic Stent Thrombosis (LAST) Events With Drug-Eluting Stents, J Am Coll Cardiol. 2005;45(12):2088-2092. doi:10.1016/j.jacc.2005.02.086 |
| (2) |
Chakravarty T, White AJ, Buch M, et al. Meta-analysis of incidence, clinical characteristics and implications of stent fracture. Am J Cardiol. 2010;106(8):1075-1080. |
| (3) |
Mauri, et al., Twelve of 30 Months of Dual Anti-platelet Therapy After Drug Eluting Stents, NEJM, 4 Dec 2014, Vol. 371, No. 23, pp 2155-2166 |
| (4) |
Dr. Tony Das, et al. "Chocolate® BAR: Chocolate® PTA in a broad range of patients with PAD, a prospective post-marketing study", LINC 2014 |
About QT Vascular
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: www.qtvascular.com
