18-Month Below-the-Knee Data with MedAlliance's SELUTION SLR(TM) Presented as Late Breaking Trial at VIVA
PR92199
GENEVA, Oct. 11, 2021 /PRNewswire=KYODO JBN/--
18-month results from the PRESTIGE* Below-the-Knee (BTK) study have been
presented as a Late Breaking Clinical Trial at VIVA21. The objective of this
clinical investigation has been to evaluate safety and performance outcomes of
SELUTION SLR(TM), MedAlliance's novel sirolimus-eluting balloon, for the
treatment of long tibial occlusive lesions (TASC C & D) in patients with
Critical Limb Ischemia (CLI).
Freedom from Target Lesion Revascularization (TLR) was exhibited by 88% of
patients and 79% demonstrated Amputation Free Survival (AFS). The rate of wound
healing was 79% and 79% of the patients improved their Rutherford score by at
least one category. The 18-month results have been sustained from the six-month
and twelve-month data.
PRESTIGE is a prospective, single-center, physician-initiated clinical
study, run at the Singapore General Hospital (SGH) by Associate Professors
Chong Tze Tec and Tang Tjun Yip, Head & Senior Consultant and Senior Consultant
respectively at the Hospital's Department of Vascular Surgery. Twenty-five
patients were enrolled with an average age of 64. 88% had diabetes mellitus and
44% had end stage renal failure. No patients required bailout stenting.
Clinical follow-up was at one, three, six, 12 and 18 months.
"We have observed minimal slow-flow phenomena, seen with other paclitaxel
drug-eluting balloons. We have observed several cases of fast wound healing
with SELUTION SLR. It is easy to track and deliver. We are looking forward to
gaining further clinical experience with this device," commented Prof. Chong.
CLI is a severe obstruction of the arteries which markedly reduces blood
flow to the extremities. It can progress to 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 challenge among patients seen with Peripheral
Artery Disease (PAD) who may benefit from this technology," commented Prof.
Tang. SGH performs over 1,000 interventional procedures a year on patients
suffering from CLI.
"We are very pleased with the 18-month BTK results in this very difficult
patient population," added MedAlliance Chairman and CEO Jeffrey B. Jump. "This
complements the excellent results we have seen in SFA, AVF and coronary
patients".
SELUTION SLR was awarded CE Mark Approval for the treatment of peripheral
artery disease in February 2020 and for the treatment of coronary arterial
disease in May 2020. The US FDA has awarded SELUTION SLR with four breakthrough
designations: for the treatment of atherosclerotic lesions in native coronary
arteries; coronary in-stent restenosis; peripheral below-the-knee and
AV-Fistula indications.
In August 2021, the first of over 3,000 patients was enrolled in a
ground-breaking coronary randomized controlled study comparing SELUTION SLR
with a limus drug-eluting stent [DES]. This is the largest DEB study ever
initiated and has the potential to change medical practice.
MedAlliance's DEB technology involves unique MicroReservoirs made from
biodegradable polymer intermixed with the anti-restenotic drug sirolimus. These
MicroReservoirs provide controlled and sustained release of the drug for up to
90 days1. Extended release of sirolimus from stents has been proven highly
efficacious in both coronary and peripheral vasculatures. MedAlliance's
proprietary CAT™ (Cell Adherent Technology) enables the MicroReservoirs to be
coated onto balloons and adhere to the vessel lumen when delivered via an
angioplasty balloon.
* Physician initiated, prospective, non-Randomized single-center trial,
investigating the safety and Efficacy of the Treatment with the Selution
Sirolimus Coated Balloon in TASC C and D Tibial occlusive disease In patients
with critical limb Ischemia from SinGaporE.
1. Drug concentration evident in MicroReservoirs and tissue – Data on file
at M.A. Med Alliance SA
Media Contact:
Richard Kenyon
kenyon@medalliance.com
+44 7831 569940
About MedAlliance
MedAlliance is a privately-owned medical technology company. It is
headquartered in Nyon, Switzerland, with offices in Germany, Singapore, UK and
USA. MedAlliance specializes in the development of ground-breaking technology
and commercialization of advanced drug device combination products for the
treatment of coronary and peripheral artery disease. For further information
visit: www.medalliance.com
Logo: https://mma.prnewswire.com/media/1196864/MedAlliance_Logo.jpg
Photo: https://mma.prnewswire.com/media/1655829/Selution_SLR_BTK_Data.jpg
Source: MedAlliance
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