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New Wearable C-PulseTM Driver ready for US Clinical Trial
16 / 05 / 2007
Sunshine Heart, Inc. (ASX: SHC) announced today it had successfully completed the development of the next generation C-PulseTM System for use in the US Feasibility Clinical Trial scheduled to commence in the second half of 2007.
The new C-PulseTM system includes a proprietary Wearable C-PulseTM Driver (pictured below) that is significantly enhanced from the version that has been used during the Australian and New Zealand Pilot Clinical Trial. It will provide patients with greater freedom and ultimately an improved quality of life.
Key features of the Wearable C-PulseTM Driver developed for the US clinical trials include:
A smaller, wearable, portable device
Comfortable ergonomic design
Evenly balanced weight of approximately 2kg
Infrared programming of the Driver by clinicians.
The Wearable C-PulseTM Driver was developed in conjunction with Sunshine Heart's development partner, the USA based Plexus Corporation. The Driver development was initiated with IPO funding in September 2004 by Sunshine Heart CEO Donald Rohrbaugh. Mr Rohrbaugh indicated that "the Plexus team of engineers worked very closely with our St Leonards engineers to achieve this significant milestone".
With delivery of the Wearable Driver, Sunshine Heart completed preclinical studies that validated all elements of the design and function of this next generation C-PulseTM System, including the Wearable Driver, the implantable Cuff and the Percutaneous Interface Lead. This pre-clinical data will form an important part of the information to be presented to the Federal Drug Administration (FDA) as part of Sunshine Heart's IDE application to commence the US Feasibility Clinical Trial.
Mr Victor Windeyer, Chief Operating Officer of Sunshine Heart said: "The completion of the preclinical studies is the final milestone in the development sequence of the C-Pulse System for the US Feasibility Clinical Trial which is scheduled to commence during the second half of 2007."
The Plexus Corporation, with sales that exceed US$1 billion, of which 26% is derived from the medical sector, will produce the Wearable C-PulseT Driver in their Chicago, IL facilities. Drivers are scheduled for delivery to Sunshine Heart in July 2007 to support the US Feasibility Clinical Trial.
The new C-PulseTM system includes a proprietary Wearable C-PulseTM Driver (pictured below) that is significantly enhanced from the version that has been used during the Australian and New Zealand Pilot Clinical Trial. It will provide patients with greater freedom and ultimately an improved quality of life.
Key features of the Wearable C-PulseTM Driver developed for the US clinical trials include:
A smaller, wearable, portable device
Comfortable ergonomic design
Evenly balanced weight of approximately 2kg
Infrared programming of the Driver by clinicians.
The Wearable C-PulseTM Driver was developed in conjunction with Sunshine Heart's development partner, the USA based Plexus Corporation. The Driver development was initiated with IPO funding in September 2004 by Sunshine Heart CEO Donald Rohrbaugh. Mr Rohrbaugh indicated that "the Plexus team of engineers worked very closely with our St Leonards engineers to achieve this significant milestone".
With delivery of the Wearable Driver, Sunshine Heart completed preclinical studies that validated all elements of the design and function of this next generation C-PulseTM System, including the Wearable Driver, the implantable Cuff and the Percutaneous Interface Lead. This pre-clinical data will form an important part of the information to be presented to the Federal Drug Administration (FDA) as part of Sunshine Heart's IDE application to commence the US Feasibility Clinical Trial.
Mr Victor Windeyer, Chief Operating Officer of Sunshine Heart said: "The completion of the preclinical studies is the final milestone in the development sequence of the C-Pulse System for the US Feasibility Clinical Trial which is scheduled to commence during the second half of 2007."
The Plexus Corporation, with sales that exceed US$1 billion, of which 26% is derived from the medical sector, will produce the Wearable C-PulseT Driver in their Chicago, IL facilities. Drivers are scheduled for delivery to Sunshine Heart in July 2007 to support the US Feasibility Clinical Trial.