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C-PulseTM Pilot Clinical Trial Abstract accepted by CSANZ
10 / 05 / 2007
Sunshine Heart, Inc (ASX: SHC) announced today that an abstract of the C-PulseTM Pilot Clinical Trial has been reviewed and accepted by the Abstract Grading Subcommittee of the Cardiac Society of Australia and New Zealand (CSANZ) Council.
Entitled "First-in-human study of a novel implantable extra-ascending aortic counterpulsation pump (C-PulseTM) in patients with end-stage heart failure", the abstract includes data from the C-PulseTM Pilot Clinical Trial, conducted across multiple clinical trial sites in Australia and New Zealand. This trial data is the foundation of the CPulseTM safety and performance to be presented to the USA Food and Drug Administration (FDA) and the US Medical Centers to position the US Clinical Trial which is scheduled to commence in 2007.
Data from the Pilot Clinical Trial will be presented at the Annual Scientific Meeting of the Cardiac Society of Australia and New Zealand to be held 9-12 August, 2007 in Christchurch, New Zealand.
At this meeting, it is expected that the medical team will present data from the trial demonstrating:
Safety of implant surgery
Improvements in the patients' heart function, and
Improvements in patient quality of life following implantation
The authors of the abstract include Drs. Paget Milsom, Peter Ruygrok, William Peters and Malcolm Legget of Auckland City Hospital; Drs. Paul Jansz and Christopher Hayward of St Vincent's Hospital, Sydney; Drs. Gerry O'Driscoll and Robert Larbalastier of Royal Perth Hospital; and Drs. Julian Smith and Betty Ho of Southern Health Monash
Medical Centre.
Entitled "First-in-human study of a novel implantable extra-ascending aortic counterpulsation pump (C-PulseTM) in patients with end-stage heart failure", the abstract includes data from the C-PulseTM Pilot Clinical Trial, conducted across multiple clinical trial sites in Australia and New Zealand. This trial data is the foundation of the CPulseTM safety and performance to be presented to the USA Food and Drug Administration (FDA) and the US Medical Centers to position the US Clinical Trial which is scheduled to commence in 2007.
Data from the Pilot Clinical Trial will be presented at the Annual Scientific Meeting of the Cardiac Society of Australia and New Zealand to be held 9-12 August, 2007 in Christchurch, New Zealand.
At this meeting, it is expected that the medical team will present data from the trial demonstrating:
Safety of implant surgery
Improvements in the patients' heart function, and
Improvements in patient quality of life following implantation
The authors of the abstract include Drs. Paget Milsom, Peter Ruygrok, William Peters and Malcolm Legget of Auckland City Hospital; Drs. Paul Jansz and Christopher Hayward of St Vincent's Hospital, Sydney; Drs. Gerry O'Driscoll and Robert Larbalastier of Royal Perth Hospital; and Drs. Julian Smith and Betty Ho of Southern Health Monash
Medical Centre.