EKOS? Endovascular Device - Ultrasound thrombolysis system pulmonary artery catheter

Држава: Аустралија

Језик: Енглески

Извор: Department of Health (Therapeutic Goods Administration)

Доступно од:

Boston Scientific Pty Ltd

Класа:

Class III

Произведен од:

Boston Scientific Corporation 300 Boston Scientific Way, Marlborough, MA, 01752 United States Of America

Терапеутска област:

59223 - Ultrasound thrombolysis system pulmonary artery catheter

Терапеутске индикације:

The system generates ultrasonic energy waves at the treatment zone through the piezoelectric transduction of radio-frequency (RF) energy generated by the Control Unit. The ultrasound emanates radially from the treatment zone into and through blood, thrombus, or tissue surrounding the treatment zone, within the patient?s vasculature. The ultrasound acts locally to increase the dispersion of the delivered physician specified fluids into the treatment region. The EKOS Endovascular Device is intended to be used with EKOS-branded control systems to employ high frequency (2 MHz -3 MHz), low power ultrasound to facilitate the infusion of physician-specified fluids, including procedural fluids and thrombolytics, into the pulmonary and/or peripheral vasculature of adults. It is intended to be used by physicians with knowledge in endovascular interventional procedures. The EKOS Endovascular System is not intended for use in the neurovasculature. The intended patient population is considered adult patients with symptomatic thrombosis in the pulmonary vessels and/or in the peripheral vasculature such as the iliac and femoral vessels.

Статус ауторизације:

A

Датум одобрења:

2022-05-10