Home

Foldax has announced completion of enrolment in the US early feasibility study of the Tria surgical aortic heart valve. According to Foldax, the Tria valve reimagines the heart valve by combining the company’s proprietary biopolymer—LifePolymer—with an innovative valve design intended to resist calcification, withstand stresses and strains without failure, and restore patient quality of life without lifelong use of anticoagulants.

“We were thrilled to participate in the first human study of the novel Tria biopolymer heart valve, which offers the potential to improve upon the durability of commonly used tissue valves today,” said Geoff Answini, chief, Division of Cardiovascular Surgery at The Christ Hospital, Cincinnati, USA, and an investigator in the study. “Several of our patients have reached one-year follow-up with good outcomes and we look forward to seeing how a polymer heart valve performs for them over time.”

“This first clinical trial of our novel Tria heart valve technology is a landmark in the heart valve replacement market as the first biopolymer valve ever to be studied in man. We have also recently commenced an early feasibility study of our surgical mitral valve and are fast-tracking development of our transcatheter aortic heart valve (TAVI). We have been pleased with the performance of the surgical aortic valve and now have over 30 patient-years of cumulative experience with patients out over two years that are off anticoagulation therapy. We are looking forward to publishing our one-year results and pursuing our IDE (investigational device exemption) with the FDA (US Food and Drug Administration),” said Frank Maguire, chief executive officer of Foldax.

The early feasibility study of the Tria surgical aortic heart valve encompassed 40 patients studied at five sites in the USA. The study was initially approved as a 15-patient study, but upon review of the initial outcomes, the FDA subsequently approved an expansion to add 25 patients.

Tria is the first and only heart valve to be robotically produced, which is possible due to its polymer leaflets that can be consistently manufactured with precise thicknesses and are designed to achieve a valve with predictable performance that lasts a lifetime.

Source CardiovascularNews

Duc Tin Clinic

Chia sẽ qua facebook bài: Enrolment completed in study of Tria aortic valve

Chia sẽ qua google bài: Enrolment completed in study of Tria aortic valve

Chia sẽ qua twitter bài: Enrolment completed in study of Tria aortic valve

Chia sẽ qua MySpace bài: Enrolment completed in study of Tria aortic valve

Chia sẽ qua LinkedIn bài: Enrolment completed in study of Tria aortic valve

Chia sẽ qua stumbleupon bài: Enrolment completed in study of Tria aortic valve

Chia sẽ qua icio bài: Enrolment completed in study of Tria aortic valve

Chia sẽ qua digg bài: Enrolment completed in study of Tria aortic valve

Chia sẽ qua yahoo bài: Enrolment completed in study of Tria aortic valve

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

Make an Appointment

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.