Hotline 24/7: 0909384389

Share links:

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

Ngày 31/03/2023 11:29 | Lượt xem: 743

Saranas has announced that it has reached the midpoint for enrolment in SAFE-MCS, a multicentre, single arm, open-label clinical trial evaluating the safety of complex high-risk percutaneous coronary intervention (PCI) using mechanical circulatory support (MCS) and surveillance with the Early Bird bleed monitoring system.

The Early Bird bleed monitoring system is the first and only US Food and Drug (FDA)-approved bleed detection system. It was launched in 2019 following a de novo classification by the FDA. The device monitors and detects endovascular bleed complications through a novel application of bioimpedance sensors.

“As the use of MCS increases worldwide, the SAFE-MCS study will bring important insight on what the true rate of bleeding events are during those procedures, and how to improve safety outcomes of patients undergoing complex and high-risk interventions,” stated Philippe Genereux (Morristown Medical Center, Morristown, USA), co-principal investigator of SAFE-MCS.

SAFE-MCS will enrol up to 265 patients across multiple centres in the USA. The primary endpoint of the study is incidence of access-site related Bleeding Academic Research Consortium (BARC) type III or V bleeding. Patients undergoing complex high-risk PCI with mechanical circulatory support (MCS) via Impella and transfemoral arterial approach are enrolled as study participants. The Early Bird bleed monitoring system is used in the ipsilateral femoral vein to monitor bleeding events after MCS removal.

“Timely identification of bleeding events is crucial in preventing adverse events that can have serious consequences for patients. The data from SAFE-MCS will provide meaningful guidance on how real-time monitoring can improve clinical outcomes through a proactive approach to managing bleeding risk,” said Babar Basir (Henry Ford Health System, Detroit, USA) and co-principal investigator of SAFE-MCS.

Saranas is partnering with the Cardiovascular Research Foundation (CRF) Clinical Trials Center to assess cost savings associated with the Early Bird in the SAFE-MCS trial. “As health systems are highly sensitive to the burden of incremental costs from procedural complications, it is more important than ever to quantify the economic value of innovative technologies like early bleed detection,” said David Cohen, director of Clinical and Outcomes Research at CRF (New York, USA).

Approximately one in every five patients will experience a bleeding complication during large-bore endovascular procedures such as transcatheter aortic valve implantation (TAVI), endovascular aneurysm repair (EVAR), and percutaneous MCS.

 

Source cardiovascularNews

Duc Tin Clinic

Tin tức liên quan

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

Neovasc shareholders approve acquisition by Shockwave Medical

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