Hotline 24/7: 0909384389

Share links:

First Aeson bioprosthetic artificial heart implanted in USA

Ngày 20/07/2021 10:05 | Lượt xem: 782

Carmat has announced the first implantation of its bioprosthetic artificial heart, Aeson, in the USA within the framework of an Early Feasibility Study (EFS).

The implant procedure was performed by a team led by Jacob N Schroder and Carmelo A Milano, surgeons at Duke University Hospital, Durham, USA. It is the first US hospital to implant Aeson within the framework of the EFS. Three additional US centres are currently screening patients for the study.

In accordance with the study protocol approved by the US Food and Drug Administration (FDA), 10 transplant-eligible patients are expected to be enrolled in this trial. The primary study endpoint is patient survival at 180 days post-implant or a successful cardiac transplantation within 180 days post-implant. It is a staged study with a progress report of the first three patients after 60 days, before the enrolment of the next seven patients.

Milano, the principal investigator of the study, stated: “We are pleased to be the first US centre to investigate a new therapeutic alternative for critically ill patients suffering from end-stage biventricular heart failure. This clinical study will help us determine whether the device’s properties—including haemocompatibility, pulsatility, autoregulation and silent operation—are beneficial to patients who currently have very few options.”

Stéphane Piat, chief executive officer of Carmat, added: “We are honoured that our device is implanted at Duke University Hospital, which is recognised throughout the USA for its quality of care and research. I would like to congratulate the teams at the hospital, as well as our technical and medical staff, on this exceptional milestone for both patients and our company. I am also very pleased that, despite the procedures hardened by the COVID-19 situation, three other centres are now fully trained and ready to join our first US clinical study that will be instrumental to our development in the world’s largest medical device market.”

Source CardiovascularNews

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