Hotline 24/7: 0909384389

Share links:

Medtronic begins early feasibility study of the Intrepid transcatheter valve system

Ngày 15/09/2020 09:03 | Lượt xem: 857

Medtronic has announced  US Food and Drug Administration (FDA) approval of an early feasibility study (EFS) of the Intrepid transcatheter tricuspid valve replacement (TTVR) system in patients with severe, symptomatic tricuspid regurgitation. This comes on the heels of a recent Breakthrough Device Designation for the Intrepid TTVR System. The Intrepid TTVR system is an investigational device worldwide.

 

“We’re beginning a new journey that we believe will open the door for the potential future treatment of patients with tricuspid valve regurgitation, who constitute a significant, patient population suffering from heart valve disease today,” said Azeem Latib, section head of interventional cardiology and medical director of structural heart interventions at Montefiore Medical Center in New York, USA and co-principal investigator in the study. “There has been much progress regarding transcatheter replacement of diseased aortic valves, but whether we can replace the tricuspid valve without open heart surgery represents a new frontier in cardiology.”

Representing a large, unmet clinical need, tricuspid regurgitation affects more than 2 million patients in the USA. It is a highly undertreated disease due to the morbidity and mortality associated with surgical intervention.

Medtronic recently received Breakthrough Device Designation by the FDA for the Intrepid TTVR system. The FDA Breakthrough Device Program is intended to help patients receive more timely access to certain technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions.

“The clinical experience generated during this initial study phase will be critical for the future of the therapy, as many of these patients are not good candidates for traditional surgical tricuspid valve interventions due to their poor right heart functions and are higher risk due to co-morbidities,” said Vinayak (Vinnie) Bapat, chief of cardiothoracic surgery at the Minneapolis Heart Institute (Minneapolis, USA) and co-principal investigator in the study. “We are optimistic that these early learnings will help fuel additional clinical research and device innovation around this treatable disease.”

The Intrepid transcatheter valve is the same valve being evaluated for the treatment of symptomatic mitral valve regurgitation in the transfemoral mitral early feasibility study. The device is implanted using a transfemoral delivery catheter, which assists physicians in delivering and placing the valve through a catheter inserted in the femoral vein.

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