Hotline 24/7: 0909384389

Share links:

Enrolment of the VasQ external support US pivotal study now complete

Ngày 06/02/2020 09:58 | Lượt xem: 1386

Laminate Medical Technologies has announced the completion of enrolment into the VasQ external support US pivotal study. The study was conducted at 17 sites across the USA and prospectively enrolled 144 male and female patients in need of an arteriovenous fistula (AVF) for haemodialysis. Both brachiocephalic and radiocephalic AVF patients were included in the study. The patients will be followed for two years with the primary endpoint of primary patency analysed at six months.

AVFs are the preferred vascular access to deliver haemodialysis treatment due to the low rates of infection and mortality relative to alternative options for patients. However, the natural biologic responses to the changes in haemodynamics and mechanical stress at the vein wall from the arterial flow tends to induce in inward tissue growth and ultimately AVF failure. Reported failure rates for AVFs are as high as 60% and require costly additional procedures to correct or a new AVF creation altogether.

VasQ is designed to address both the haemodynamic and mechanical factors associated with AVF failure. The device is a nitinol external support placed around the artery and vein at the creation site that optimises the transition of arterial flow to the vein while reinforcing the vessel wall against the increase in mechanical stress. VasQ patients in Europe have demonstrated increased rates of receiving a usable AVF with fewer early failures and additional procedures in multiple prospective and retrospective studies. The clinical benefits of VasQ experienced in Europe are expected to be validated in the US dialysis patient population within this fully enrolled pivotal study.

Ellen Dillavou of Duke University (Durham, USA) stated: “VasQ promises to be a new standard of care for fistula creation to give my haemodialysis patients the greatest probability of success. The device has performed as expected in my study patients so far, and I look forward to continue to utilise it once commercially available in the USA.”

“We are grateful to our principle investigators for their commitment to this study,” said Laminate CEO Tammy Gilon. “The results will be an important addition to the mounting evidence supporting the benefits of VasQ to promote the usability of both forearm and upper arm fistulas.”

Source VascularNews

Duc Tin Clinic

Tin tức liên quan

Vesteck completes first-in-human use of several Suture-Tight devices

Age is just a number: Individual patient data meta-analysis probes safety of CEA in the elderly

Artificial intelligence can predict risk of complications after endovascular aneurysm repair

Bluegrass Vascular announces Journal of Vascular Surgery paper reporting use of Surfacer system

Vascular access creation: EndoAVF keeps future options open, but is not a replacement for surgical fistulas

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