Final Results From Below-The-Knee Cohort In Chocolate Registry Presented At The 5th Annual Amputation Prevention Conference

Monday, August 31, 2015

PLEASANTON, Calif., Aug. 31, 2015 /PRNewswire/ -- QT Vascular Ltd., together with its subsidiaries (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 today the final results of the below-the-knee ("BTK") cohort of patients in the Chocolate® Balloon Angioplasty Registry ("BAR") which were presented on August 15, 2015 at the 5th Annual Amputation Prevention Symposium in Chicago, Illinois by the Principal Investigator, Dr. Jihad Mustapha, of Metro Health Hospital, Wyoming, Michigan.

Based on historical outcomes with conventional balloon angioplasty reported in the literature1-3, BTK patients treated with Chocolate® percutaneous transluminal angioplasty ("PTA") Balloon Catheter ("Chocolate® PTA") in this study showed a lower rate of unplanned stenting, a lower rate of repeat interventions, a lower incidence of amputation and lower overall mortality. A randomized controlled study would further define the potential treatment benefit of the Chocolate® PTA for BTK lesions.

Outcomes

Chocolate® PTA

Conventional PTA 1-3

Procedural





Bail-out stent placement

4.9%

9.9%

30 days





Target lesion revascularization

2.2%

8.1%

Major amputation

1.3%

4.4-6.6%

Mortality

0.9%

1.7-3.3%

 

Outcomes

Chocolate® PTA

Conventional PTA 1-3

6 months





Target lesion revascularization

9.0%

16.0%

Major amputation

3.2%

11.8%

Mortality

2.9%

7.7%

"A significant part of my practice is treating patients with BTK disease. These patients have more progressed disease and are often at risk for higher complication rate including amputation and even death," commented Dr. Mustapha. "The results from Chocolate® BAR are very positive. Drug coated balloons have not yet shown to be effective for interventions below the knee. With Chocolate® PTA, even without a drug, we now have the tool to improve outcomes in this very sick group of patients."

The Chocolate® BAR is an observational registry collecting data on real world use with the Chocolate® PTA to assess its effectiveness in achieving optimal PTA procedural outcomes and to assess potential longer-term clinical benefits. A total of 226 BTK patients were enrolled and agreed to undergo three months follow-up and a cohort of 123 patients was scheduled for six months follow-up. In addition, 264 above-the-knee ("ATK") patients were enrolled for a total of 490 patients treated at 33 US centers. The final results for the ATK patient cohort will be presented later in 2015.

"It is very gratifying to see patients treated with Chocolate® PTA to have low rates of bail-out stenting, repeat interventions, and amputations. The BTK patients are in a need for a solution and the results of the Chocolate® BAR are encouraging," stated Dr Eitan Konstantino, PhD, Chief Executive Officer of QT Vascular. "We are focused on continued innovation and believe that our pipeline of drug coated devices will add meaningful value to patients and healthcare providers."

1. Razavi MK, Mustapha JA, Miller LE. Contemporary systematic review and meta-analysis of early outcomes with percutaneous treatment for infrapopliteal atherosclerotic disease. Jour of Vasc and Intervent Radiol : JVIR 2014;25:1489-96, 96 e1-3.

2. Romiti M, Albers M, Brochado-Neto FC, Durazzo AE, Pereira CA, De Luccia N. Meta-analysis of infrapopliteal angioplasty for chronic critical limb ischemia. J Vasc Surg 2008;47:975-81.

3. Boisers, Marc on behalf of AMS investigators. 6-Month Analysis AMS INSIGHT—Absorbable Metal Stent Implantation for Treatment of Below-the-Knee Critical Limb Ischemia:  6-Month  Analysis.  Cardiovasc Intervent Radiol (2009) 32:424–435 (PTA control group)

ABOUT QT VASCULAR LTD. (SGX Stock code: 5I0)

QT Vascular Ltd. together with its subsidiaries ("QT Vascular" or the "Group"), is an emerging leader in the development and commercialization of next generation minimally invasive products for the treatment of complex vascular disease. QT Vascular 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 ("TriReme Medical"), based in Pleasanton, California. TriReme Medical's range of percutaneous transluminal angioplasty ("PTA") and percutaneous transluminal coronary angioplasty ("PTCA") products include (i) Chocolate® PTA Balloon Catheter, (ii) Chocolate® PTCA Balloon Catheter, (iii) GliderXtremeTM PTA Balloon Catheter, (iv) GliderfleX® PTA Balloon Catheter; and (v) GliderTM PTCA Balloon Catheter, all of which have the CE Mark that allows them to be sold in Europe, and FDA clearance to be sold in the United States. Additionally, the GliderXtremeTM PTA Balloon Catheter has the regulatory clearance in China and Japan, while the GliderTM PTCA Balloon Catheter has the regulatory clearance in Japan. These products are mainly sold through its main distributors: (i) Cordis Corporation (a wholly-owned subsidiary of Johnson & Johnson), (ii) Shandong Weigao Group Medical Polymer Co Ltd and (iii) Century Medical, Inc.

The Group has also applied for CE marking approval with respect to the Chocolate® Touch, its advanced drug-coated peripheral balloon.

For more information, please visit the company website at www.qtvascular.com

 

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SOURCE QT Vascular Ltd.

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