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Safety and Effectiveness of the Device Nit-Occlud® PDA-R

2014-07-23 21:10:47 | BioPortfolio

Summary

The purpose of this study is to evaluate the safety and the effectiveness of the device Nit-Occlud® PDA-R in the percutaneous closure of patent ductus.

Description

During the years 2003 to 2008, Kardiozentrum evaluated 1136 patients with echocardiographic studies, 14.7% of the patients were diagnosed with patent ductus arterious (PDA). The device "Nit- occlud® PDA-R" is a medical implant, developed for closure of patent ductus arterious (PDA) or ductus, which is an abnormal communication between the aorta and pulmonary artery. Untreated it can rise the intrapulmonary pressure and lead to serious complications like cardiac insufficiency.

The incidence of ductus as an isolated heart disease is between 3,6 and 7% of all the congenital heart diseases at sea level, and 10 - 14% in the altitude; rising up to 20% in cities at more than 2.500 m about sea level. The ductus' in high altitude are generally wider and larger than at sea level.

The device performs the function of generating the defect occlusion by the body itself. The implant stimulates the body to generate an epithelium over the implant so that the ductus closes. The Nit Occlud® PDA-R system is placed inside of the great arteries with a technique called minimally invasive cardiac catheterization. The implementation of the Nit-occlud® PDA-R system is developed for closure of patent ductus with 2 to 8 mm minimal diameter.

Study Design

Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Conditions

Congenital Heart Disease

Intervention

Nit-Occlud® PDA-R

Location

Kardiozentrum and Surgical Medical Center Boliviano Belga
La Paz
Murillo
Bolivia
100

Status

Recruiting

Source

pfm S.R.L.

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:10:47-0400

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