TEL AVIV, Israel, Feb. 23, 2018 /PRNewswire/ -- Vascular Grafts Solutions announced today the interim results from the VEST III study, a post-marketing trial which evaluates the effectiveness of the VEST technology (Venous External SupporT) in treatment of saphenous vein graft (SVG) disease after coronary artery bypass grafting.
The Interim results of the entire patients' cohort from Barmherzigen Brüder hospital, in Trier Germany, were presented at the DGTHG meeting in Leipzig, by Prof. Ivar Friedrich. The cohort included 35 patients (mean age 66.0 ± 7.1 years, 97% males) with multi-vessel disease that underwent CABG between October 2015 and January 2017. In addition to an internal mammary artery graft, each patient received one external stent (VEST, Vascular Graft Solutions, Israel) to a single SVG randomized to either the right or left coronary territories while one or more non-stented SVG served as control. Graft patency was evaluated at 6 months using CT angiography.
Prof. Friedrich reported that all SVGs were harvested in an open manner and that VEST - external stent deployment was successful in 100% of patients. In addition, transient time flow measurements and pulsatility indices in the stented and non-stented groups were 36.1±14.8 and 2.0±0.8 and 37.42±15.2 and 2.3±1.3 respectively. Overall MACCE rate was 8.3% during the reported study period (mean follow-up 481 days, range 229-681 days). Six month CT angiography has been completed for all 35 patients (100% follow-up). Early patency of LIMA grafts was 100% (35/35). Early patency of stented SVG to the right and left territories were 100% (17/17) and 100% (18/18) respectively compared to 100% (18/18) and 94.4% (17/18) in the non-stented group. "After 50 years of using veins as bypass grafts in cardiac surgery, we finally have a promising technology to target vein graft degeneration". said Professor Ivar Friedrich.
VEST received CE mark approval in 2015, and has been implanted successfully in more than 1,000 patients in leading European heart centers. To date, it is the only technology that demonstrated clinical effectiveness in mitigation of vein graft disease five years after surgery.
"To the best of our knowledge, this is the first clinical group that report 100% early patency rates from a randomized controlled cohort of externally stented grafts," said Eyal Orion, founder and CEO of VGS. "We are honored and privileged to develop, together with cardiac surgeons, breakthrough technologies that will restate CABG and position it as a definitive treatment for severe coronary disease. This report, joins our previous publications from VEST I and VEST II trials that demonstrated significant beneficial effect of VEST on vein grafts disease."
About VEST VEST - Venous External SupporT, is a kink resistant cobalt-chromium external support applied on the outer surface of saphenous vein grafts when used in CABG surgery. Its unique mechanical properties enable the surgeon to design its geometry during the procedure and optimize the dimensional match with the graft. VEST is designed to target the underlying factors leading to vein graft disease; disturbed flow pattern, high wall tension and in particular, progression of vein graft disease (intimal hyperplasia).
VEST is CE Marked and commercially available in Europe, Mexico and South-Africa. In the U.S., VEST is an investigational device and is not available for sale.
About Vascular Graft SolutionsVascular Graft Solutions Ltd, a privately held medical device company Based in Tel-Aviv, Israel, was founded in 2009. The company is devoted to the development, manufacturing and marketing of medical technologies in cardiac and vascular surgery with market leading innovations and industry-leading pipeline.
Rotem KatzenellenbogenVP Business [email protected] +972-3-549-9054
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The Interim results of the entire patients' cohort from Barmherzigen Brüder hospital, in Trier Germany, were presented at the DGTHG meeting in Leipzig, by Prof. Ivar Friedrich. The cohort included 35 patients (mean age 66.0 ± 7.1 years, 97% males) with multi-vessel disease that underwent CABG between October 2015 and January 2017. In addition to an internal mammary artery graft, each patient received one external stent (VEST, Vascular Graft Solutions, Israel) to a single SVG randomized to either the right or left coronary territories while one or more non-stented SVG served as control. Graft patency was evaluated at 6 months using CT angiography.
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Prof. Friedrich reported that all SVGs were harvested in an open manner and that VEST - external stent deployment was successful in 100% of patients. In addition, transient time flow measurements and pulsatility indices in the stented and non-stented groups were 36.1±14.8 and 2.0±0.8 and 37.42±15.2 and 2.3±1.3 respectively. Overall MACCE rate was 8.3% during the reported study period (mean follow-up 481 days, range 229-681 days). Six month CT angiography has been completed for all 35 patients (100% follow-up). Early patency of LIMA grafts was 100% (35/35). Early patency of stented SVG to the right and left territories were 100% (17/17) and 100% (18/18) respectively compared to 100% (18/18) and 94.4% (17/18) in the non-stented group. "After 50 years of using veins as bypass grafts in cardiac surgery, we finally have a promising technology to target vein graft degeneration". said Professor Ivar Friedrich.
VEST received CE mark approval in 2015, and has been implanted successfully in more than 1,000 patients in leading European heart centers. To date, it is the only technology that demonstrated clinical effectiveness in mitigation of vein graft disease five years after surgery.
"To the best of our knowledge, this is the first clinical group that report 100% early patency rates from a randomized controlled cohort of externally stented grafts," said Eyal Orion, founder and CEO of VGS. "We are honored and privileged to develop, together with cardiac surgeons, breakthrough technologies that will restate CABG and position it as a definitive treatment for severe coronary disease. This report, joins our previous publications from VEST I and VEST II trials that demonstrated significant beneficial effect of VEST on vein grafts disease."
About VEST VEST - Venous External SupporT, is a kink resistant cobalt-chromium external support applied on the outer surface of saphenous vein grafts when used in CABG surgery. Its unique mechanical properties enable the surgeon to design its geometry during the procedure and optimize the dimensional match with the graft. VEST is designed to target the underlying factors leading to vein graft disease; disturbed flow pattern, high wall tension and in particular, progression of vein graft disease (intimal hyperplasia).
VEST is CE Marked and commercially available in Europe, Mexico and South-Africa. In the U.S., VEST is an investigational device and is not available for sale.
About Vascular Graft SolutionsVascular Graft Solutions Ltd, a privately held medical device company Based in Tel-Aviv, Israel, was founded in 2009. The company is devoted to the development, manufacturing and marketing of medical technologies in cardiac and vascular surgery with market leading innovations and industry-leading pipeline.
Rotem KatzenellenbogenVP Business [email protected] +972-3-549-9054
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SOURCE Vascular Grafts Solutions
