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PRODUCT

PULSTA™

PULSTA™ Transcatheter Pulmonary Valve System

PULSTA™ Transcatheter Pulmonary Valve System.
KFDA approved (MFDS)

Video clip

Indication



For patients who require pulmonary valve replacement due to pulmonary valve regurgitation and/or stenosis

Features

● Self-expandable valve with Knitted-wire backbone

   - no need to do pre-stent and applicable for native right ventricular outflow tract


● Various valve sizes up to 32mm


● Multi-step tissue engineering for longer durability


● Easy access and deployment at the main pulmonary artery landing zone
   - low profile delivery system (18, 20 French) 
   - rather short loading length


● Simple and Easy Valve loading procedure

Articles

● Novel self-expandable, stent-based transcatheter pulmonic valve : a preclinical animla study.

Kim GB, Lim HG, Kim YJ, Choi EY, Kwon BS, Jeong S [Int J Cardiol. 2014 Apr 15;173(1):74-9.]


● First in human experience of a new self-expandable percutaneous pulmonary valve implantation using knitted nitinol-wire and tri-leaflet porcine pericardial valve in the native right ventricular outflow tract.
Catheter Cardiovasc Interv. 2017 Apr;89(5):906-909 Kim GB


● Successful Feasibility Human Trial of a New-Self-Expandable Percutaneous Pulmonary Valve (Pulsta™ Valve) Implantation Using Knitted Nitinol Wire Backbone and Trileaflet α-Gal-Free Porcin Pericardial Valve in the Native Right Ventricular Outflow Tract.
Circ Cardiovasc Interv. 2018 Jun; 11(6): e006494 Kim GB


● Early Outcomes of Percutaneous Pulmonary Valve Implantation with Pulsta and Melody valves : the First Report from Korea

Choi JY, Kim AY, Jung JW, SHing JI, EUN YM, Kim NK. [J. Clini. Med. 2020, 9, 2769; doi:10.3390/jcm909269]


● Mid-term outcomes of the Pulsta transcatheter pulmonary valve for the native right ventricular outflow tract

Lee S-Y, Kim GB, Kim S-H, Jang S-I, Choi JY, Kang IS, et al. [Catheter Cardiovasc Interv. 2021; 1-9, https://doi.org/10.1002/ccd.29865]


● Bilateral branch pulmonary artery Pulsta valve implantation for treatment of large right ventricular outflow tract in a high-risk patient

KIM JY, KIM  S-H, Jang SI [Catheter Cardiovasc Interv. 2021;1-5. https://doi.org/10.1002.ccd.29857]


● Early results of Pulsta transcatheter heart valve in patients with enlarged right ventricular outflow tract and severe pulmonary regurgitation due to transannular patch 

Odemis E, Yenidogan I, and Kizilkaya MH [Cardiology in the Young, 2022, page 1 of 9, doi: 10.1017/S1047951122003511]


● Outcomes of Transcatheter Pulmonary Valve Replacement and Surgical Pulmonary Valve Replacement : A Cohort Analysis 

Kritvikrom Durongpisitkul et al. [Journal of the Society for Cardiovascular Angiography & Interventions, 2022, DOI:https://doi.org/10.1016/j.jscai.2022.100408]


● Self-expanding Pulmonary Valves in Fifty-Three Patients with Native Repaired Right Ventricular Outflow Tracts 

Jou-Kou Wang et al. [Canadian Journal of Cardiology (2023), doi: https://doi.org/10.1016/j.cjca.2023.03.013]