Hotline 24/7: 0909384389

Share links:

Myval: India’s TAVI technology is now going global

Ngày 14/08/2019 07:23 | Lượt xem: 1412

The Myval transcatheter aortic valve implantation (TAVI) system, designed and manufactured by Meril Lifesciences in India, recently received the CE mark for the management of severe aortic stenosis. In this commentary, Ashok Seth discusses his experience with the Myval system, and the recent MyVal-1 study, one-year data of which he presented as a principal investigator at EuroPCR 2019 (20–24 May, Paris, France).

The Myval valve is a next-generation balloon expandable heart valve made up of a nickel cobalt alloy frame and bovine pericardium leaflets. The valve has a unique hybrid honeycomb cell design, with open cells on the upper half to ensure unjailing of the coronary ostia and closed cells on the lower half for high radial strength. Upon crimping, this design gives a unique “dark and light” band pattern, visible under fluoroscopy, ensuring accurate valve positioning and orthotopic deployment.

Ensuring easy delivery of a transcatheter heart valve 

The valve comes with an internal polyethylene terephthalate (PET) sealing cuff and an external PET buffing to minimise paravalvular leaks. This CE-approved valve comes in seven sizes from 20mm–29mm. The Myval is directly crimped on a stent balloon delivery system, which has a stopper at either end to prevent valve movement and migration during delivery. There is no sheath over the valve, hence the valve delivery system behaves like a direct stent implantation system without the need for multiple steps and adjustment. The Myval goes through a 14F python lubricated introducer sheath for percutaneous access of the crimped Myval.

The Myval system is an innovative step towards treating severe aortic stenosis. A major benefit of this technology is the simplicity of the navigator delivery system, with its operator friendly rotatory handle. I have personally experienced the ease of navigation in challenging anatomies due to its hi-flexion distal shaft. It is intuitive and simpler to use, similar to implanting a coronary stent. In addition, the 14F python sheath also enables full retrieval of the Myval crimped balloon catheter.

MyVal

MyVal-1 study met its primary endpoint

TAVI is now a well-established treatment for aortic stenosis, and is approved as an alternative to surgical aortic valve replacement in high-risk and intermediate-risk patients. The CE and CDSCO-India approval for Myval for its use in TAVI was based on successful results from the MyVal-1 study.

MyVal-1 is a first-in-human, prospective, multicentre, single-arm, open label study of Myval for the treatment of severe symptomatic native aortic valve stenosis, which enrolled 30 patients and intends to follow-up for five years.

Myval received CE approval in May 2019. Results of the one-year MyVal-1 study, which I presented on behalf on the study investigators, at a late-breaking trial session at EuroPCR 2019, showed 100% device success and a zero device-related mortality rate. There were no new pacemaker implantations, no strokes, and no paravalvular leaks observed in the trial patients.

Furthermore, echo parameters were maintained at 12-month follow-up, and there was a marked improvement from baseline to 12 months in quality of life scores, as measured by the six-minute walk test, New York Heart Association (NYHA) functional class and the Kansas City Cardiomyopathy Questionnaire score. At the time of the valve implantation, 70% patients were NYHA class III/class IV. At one-year, 80.77% of the patients had improved to NYHA class I, and the remainder to NYHA class II.

Based on these encouraging first-in-human results, further studies are being planned in a larger population and differing geographies for longer durations of time.

This device is not approved for sale in the USA.

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