{"id":8444,"date":"2021-01-28T05:26:36","date_gmt":"2021-01-28T05:26:36","guid":{"rendered":"http:\/\/www.bioindiaservices.com\/bio3\/?p=8444"},"modified":"2022-04-06T06:39:18","modified_gmt":"2022-04-06T06:39:18","slug":"12-month-below-the-knee-data-with-medalliances-selution-slr-presented-a-late-breaking-trial-at-linc","status":"publish","type":"post","link":"http:\/\/www.bioindiaservices.com\/bio3\/technology\/12-month-below-the-knee-data-with-medalliances-selution-slr-presented-a-late-breaking-trial-at-linc\/","title":{"rendered":"12-Month Below-the-Knee Data with MedAlliance’s SELUTION SLR\u2122 Presented a Late Breaking Trial at LINC"},"content":{"rendered":"\n
NYON, Switzerland, Jan. 28, 2021 (PRNewswire)<\/span><\/h5>\n\n\n\n

12-month results from the PRESTIGE Below-the-Knee (BTK) studyhave been presented as a Late Breaking Trial at LINC 2021. The objective of this clinical investigation has been toevaluate safety and performance outcomes of SELUTION SLRTM,MedAlliance’s novel sirolimus-eluting balloon, for thetreatment of long tibial occlusive lesions (TASC C & D) in patients with Critical Limb Ischemia (CLI).<\/p>\n\n\n\n

The Primary Patency Rate was 78% and the rate of wound healing was 81%. Freedom from Target Lesion
Revascularization (TLR) was exhibited by 93% of patients and 84% demonstrated Amputation Free Survival
(AFS). All these figures have been sustained from the six-month data.
PRESTIGE is a prospective, single-center, physician-initiated clinical study, run at the Singapore GeneralHospital (SGH) by Associate Professor Tze Tec Chong and Dr.Tjun Yip Tang, who are both Senior
Consultants at the Hospital’s Department of Vascular Surgery. Twenty-five patients were enrolled with anaverage age of 64. 88% had diabetes mellitus and 44% had end stage renal failure. No patients required bailoutstenting. Clinical follow-up was at one, three, six and 12 months.
“We have observed minimal slow-flow phenomena and some cases of fast wound healing with this balloon.
It is also easy to track and deliver. We are looking forward to gaining further clinical experience with thisdevice,” commented Prof. Chong.
CLI is a severe obstruction of the arteries which markedly reduces blood flow to the extremities. It can progressto the point of severe pain and skin ulcers or sores: CLI often leads to amputation.
Singapore has a high percentage of diabetics in its population and CLI therefore constitutes a major challengeamong patients seen with Peripheral Artery Disease (PAD). SGH performs over 1,000 interventionalprocedures a year on patients suffering from CLI.
“We are very pleased with the one-year BTK results in this very difficult patient population”, addedMedAlliance Chairman and CEO Jeffrey B. Jump. “This complements the excellent results we have seen inSFA and coronary patients”.
In February 2020 MedAlliance received CE Mark approval for SELUTION SLR in the treatment of peripheralartery disease. Both the STEP Pedal Arch study and SUCCESS PTA, a large post marketing clinical study inPAD, will commence enrolment soon. In the US, SELUTION SLR has received US Food and DrugAdministration (FDA) Breakthrough Device Designation Status for a DEB in the treatment of peripheralbelow-the-knee lesions.<\/p>\n\n\n\n

SELUTION SLR’s technology involves unique MicroReservoirs made from biodegradable polymerintermixed with the anti-restenotic drug sirolimus. These MicroReservoirs provide controlled and sustainedrelease of the drug. Extended release of sirolimus from stents has been proven highly efficacious in bothcoronary and peripheral vasculatures. MedAlliance’s proprietary CATTM (Cell Adherent Technology) enablesthe MicroReservoirs to be coated onto balloons and adhere to the vessel lumen when delivered via anangioplasty balloon.<\/p>\n\n\n\n

<\/p>\n","protected":false},"excerpt":{"rendered":"

NYON, Switzerland, Jan. 28, 2021 (PRNewswire) 12-month results from the PRESTIGE Below-the-Knee (BTK) studyhave been presented as a Late Breaking Trial at LINC 2021. The objective of this clinical investigation has been toevaluate safety and performance outcomes of SELUTION SLRTM,MedAlliance’s novel sirolimus-eluting balloon, for thetreatment of long tibial occlusive lesions (TASC C & D) in […]<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":[],"categories":[6],"tags":[],"_links":{"self":[{"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/posts\/8444"}],"collection":[{"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/comments?post=8444"}],"version-history":[{"count":6,"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/posts\/8444\/revisions"}],"predecessor-version":[{"id":10564,"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/posts\/8444\/revisions\/10564"}],"wp:attachment":[{"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/media?parent=8444"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/categories?post=8444"},{"taxonomy":"post_tag","embeddable":true,"href":"http:\/\/www.bioindiaservices.com\/bio3\/wp-json\/wp\/v2\/tags?post=8444"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}