View all newsletters
Receive our newsletter – data, insights and analysis delivered to you
  1. Market Data
November 9, 2011updated 11 Feb 2022 6:43am

Sunshine C-Pulse system found effective against cardiovascular disorder

Sunshine Heart has presented the results of a US Food and Drug Administration-approved feasibility study of the C-Pulse heart assist system.

Sunshine Heart has presented the results of a US Food and Drug Administration-approved feasibility study of the C-Pulse heart assist system.

The C-Pulse system uses the intra-aortic balloon counter-pulsation principle to reduce the workload required to pump blood throughout the body, and increase blood flow to the coronary arteries.

In the feasibility study, 18 patients with ACC/AHA Stage C New York Heart Association Class III heart failure and two patients with ambulatory Class IV heart failure were implanted with the C-Pulse system.

It was found that after six months, C-Pulse therapy produced considerable improvements in class reduction, quality of life and left ventricular ejection fraction.

The primary endpoints included device-related death, neurological dysfunction, aortic disruption, myocardial infarction, major infection and any other device-related adverse events through six months.

National co-lead principal investigator William Abraham said a prospective multicentre trial to further assess the safety and efficacy of C-Pulse system is planned.

Sunshine Heart CEO Dave Rosa said the company plans to work with the FDA to gain permission to initiate a pivotal trial in the US next year.

Related Companies

NEWSLETTER Sign up Tick the boxes of the newsletters you would like to receive. The top stories of the day delivered to you every weekday. A weekly roundup of the latest news and analysis, sent every Friday. The medical device industry's most comprehensive news and information delivered every month.
I consent to GlobalData UK Limited collecting my details provided via this form in accordance with the Privacy Policy
SUBSCRIBED

THANK YOU