Hotline 24/7: 0909384389

Share links:

12-month BTK data with MedAlliance’s SELUTION SLR presented as late-breaking trial

Ngày 01/02/1988 12:06 | Lượt xem: 808

Twelve-month results from the PRESTIGE below-the-knee (BTK) study have been presented as a late-breaking trial at LINC 2021(The Leipzig Interventional Course; 25–29 January, online). The objective of this clinical investigation has been to evaluate safety and performance outcomes of SELUTION SLR, MedAlliance’s novel sirolimus-eluting balloon, for the treatment of long tibial occlusive lesions (TASC C and D) in patients with chronic limb-threatening ischaemia (CLTI).

The primary patency rate was 78% and the rate of wound healing was 81%. Freedom from target lesion revascularisation (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-centre, physician-initiated clinical study, run at the Singapore General Hospital (SGH) by Tze Tec Chong and Tjun Yip Tang, who are both senior consultants at the Hospital’s Department of Vascular Surgery. Twenty-five patients were enrolled with an average age of 64. Eighty-eight per cent had diabetes mellitus and 44% had end stage renal failure. No patients required bailout stenting. 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 SELUTION SLR. It is also easy to track and deliver. We are looking forward to gaining further clinical experience with this device,” commented Chong.

Singapore has a high percentage of diabetics in its population and CLTI therefore constitutes a major challenge among patients seen with peripheral arterial disease (PAD). SGH performs over 1,000 interventional procedures a year on patients suffering from CLTI.

In February 2020 MedAlliance received CE mark approval for SELUTION SLR in the treatment of peripheral arterial disease. Both the STEP Pedal Arch study and SUCCESS PTA, a large post-marketing clinical study in PAD, will commence enrolment soon. In the US, SELUTION SLR has received US Food and Drug Administration (FDA) Breakthrough Device Designation Status for a drug-eluting balloon (DEB) in the treatment of peripheral below-the-knee lesions.

Source VascularNews

Duc Tin Clinic

Tin tức liên quan

Enrolment reaches midway point in trial of Early Bird bleed monitoring system

Eight-fold increased risk of heart attack seen in patients with subclinical obstructive coronary atherosclerosis

ACC 2023: REVIVED-BCIS-2 results challenge “long-held beliefs” on myocardial viability testing prior to PCI

Blood pressure successfully cut in RADIANCE II ultrasound renal denervation trial

New data examine mortality rates and cardiac damage in early-stage aortic stenosis patients

SUPPORT CONSULTANT

CUSTOMER REVIEWS

• I am Nguyen Thanh Sang, born in 1990. Since the examination and treatment at the clinic Duc Tin, I am very grateful to the Doctor for explaining and sharing about my illness. During the treatment time in the clinic I was very caring staff of the clinic. Now my illness has improved in a good way. Expect more and more clinic to be able to save many patients.

  I sincerely thank you !. Tel: 0938303275

• Huynh Thi Muoi, born in 1940, was examined and treated at Duc Tin Clinic. I am very pleased about how to serve and care patients of the clinic. The doctor is committed to explaining and sharing with the patient.

  Huynh Thi Muoi sincerely thank you! Phone number: 0972868746

• As I said Duc Tin surgical clinin is where my family trust, hope to visit. Physicians caring, thoughtful, gentle to the patient. Nurses and staff clinic polite, cheerful and thoughtful. This clinic clean, sterile, so I would love to. Tel: +84949914060.

• The doctor is very caring, attentive and very gentle nurse, courteous, affable with me. The clinic is clean, comfortable, polite. I enjoyed this faith. Every visit I was very relieved disease. Tel: 0839820792.

• I was patient, had to clinics of Dr. Le Duc Tin. I see very conscientious doctor patient care, answer any questions and very dedicated staff from the receptionist to the children tested, nursing. Clinics very clean and spacious. I'm very satisfied. Tel: +841227880829.

Search

News

Customer support