Myosist™

Primary DI

18904224917320

Basic UDI-DI Code

B-18904224917320

Reference

MYS0840

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 3

Status

On The Market

Manufacturer

Meril Life Sciences Pvt. Ltd.

The MYOSIST™ kit is designed to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.The Kit comprises MYOSIST Catheter Tray and TM Accessories Tray. Kit is composed of a specially designed Y-connector, an inner lumen, radio-opaque marker bands, outer shaft, protector sleeve, suture wing, catheter extension tube, male luer connector, Luer Cap and a highly flexible balloon attached with the radiopaque catheter tip.The radiopaque catheter tip ensures the placement of the catheter tip 2-3 cm below the subclavian artery in the descending aorta under fluoroscopy.The Balloon has two radiopaque marker bands that represent the approximate Balloon length when inflated at its nominal pressure.The radiopaque markers ensures the accurate positioning of the balloon between subclavian artery and renal artery under fluoroscopy.The gap between outer shaft and inner lumen serves as Helium Gas transfer medium for balloon inflation/deflation.The Y-connector, having two ports of which, One port allows easy Guidewire passage and another port allows Helium Gas transition for inflation/deflation.The Stylet bonded with Luer Lock Cap, is fitted with the Guidewire port of the Y-Connector.Stylet is placed into the inner lumen to prevent the catheter from kinking prior to use.The strain relief is attached to the Y-Connector provides the transition in flexibility between Y-Connector and Outer Shaft.Protector sleeve is placed over the outer shaft and is used to prevent from contamination.Suture wing helps in stabilizing catheter by suturing with skin. Silicon Coating covers the balloon and forms a lubricious outer surface which become very slippery promptly upon being wet. A balloon protective sheath is placed over the balloon to prevent any damage to the balloon before use.

Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).