News & Events
< Back to News Overview
C-PulseTM Pilot Clinical Trial Results Presented FDA Meeting Scheduled for US Clinical Trial
14 / 08 / 2007
Sunshine Heart, Inc (ASX: SHC) announced today that the results of the C-PulseTM Pilot Clinical Trial were presented by Mr Paget Milsom FRACS at the Annual Scientific Meeting of the Cardiac Society of Australia and New Zealand (CSANZ) on Saturday 11 August, 2007 in Christchurch, New Zealand. Mr Milsom, Director of Cardiothoracic Surgery at Auckland City Hospital was principal investigator for the C-Pulse Pilot Trial.
At the meeting, Mr Milsom presented final consolidated data from the multi-centre Australasian pilot trial conducted at Auckland City Hospital in Auckland, New Zealand; Southern Health Monash Medical Centre, Melbourne; Royal Perth Hospital, Perth; and
St Vincent;s Hospital, Sydney. The trial demonstrated:
Safety of implant surgery
Improvements in the patients' heart function, and
Improvements in patient quality of life following implantation.
Dr William Peters, Sunshine Heart's Medical Director, indicated that "the results were well received by the physicians in attendance at the CSANZ presentation. Furthermore,
attendees at the concurrent investigator's meeting expressed strong interest in participating in a similar study to the USA Food and Drug Administration (FDA) trial with the new wearable C-Pulse system".
Also attending the conference was Professor William Abraham, MD, of Ohio State University, who will serve as co-lead national principal investigator in the C-Pulse feasibility clinical trial at six premier U.S. medical institutions. It should be noted that the
data presented at the Conference formed the foundation of the C-Pulse safety and performance data presented to the FDA in the Company's Investigation Device Exemption (IDE) submission which was filed on 13 June 2007.
Sunshine Heart's executives along with Dr Abraham will be meeting to consult with representatives from the FDA in early September in regards to various aspects of the Company's IDE application. Following this meeting, Sunshine Heart CEO, Mr Don
Rohrbaugh, expects the company to file a supplement to the IDE application, and hopes to commence the feasibility phase prior to year-end, making it the first company in the world to trial a non-blood contacting heart assist device in the United States.
Mr Rohrbaugh further commented that "many therapies receive feedback requiring consultation with the FDA, and we look forward to meeting with them later this month to address their comments. Once our IDE application is approved, we expect that the feasibility trial will enable Sunshine Heart to provide this unique therapy to moderate heart failure patients who represent a significant unmet clinical need."
At the meeting, Mr Milsom presented final consolidated data from the multi-centre Australasian pilot trial conducted at Auckland City Hospital in Auckland, New Zealand; Southern Health Monash Medical Centre, Melbourne; Royal Perth Hospital, Perth; and
St Vincent;s Hospital, Sydney. The trial demonstrated:
Safety of implant surgery
Improvements in the patients' heart function, and
Improvements in patient quality of life following implantation.
Dr William Peters, Sunshine Heart's Medical Director, indicated that "the results were well received by the physicians in attendance at the CSANZ presentation. Furthermore,
attendees at the concurrent investigator's meeting expressed strong interest in participating in a similar study to the USA Food and Drug Administration (FDA) trial with the new wearable C-Pulse system".
Also attending the conference was Professor William Abraham, MD, of Ohio State University, who will serve as co-lead national principal investigator in the C-Pulse feasibility clinical trial at six premier U.S. medical institutions. It should be noted that the
data presented at the Conference formed the foundation of the C-Pulse safety and performance data presented to the FDA in the Company's Investigation Device Exemption (IDE) submission which was filed on 13 June 2007.
Sunshine Heart's executives along with Dr Abraham will be meeting to consult with representatives from the FDA in early September in regards to various aspects of the Company's IDE application. Following this meeting, Sunshine Heart CEO, Mr Don
Rohrbaugh, expects the company to file a supplement to the IDE application, and hopes to commence the feasibility phase prior to year-end, making it the first company in the world to trial a non-blood contacting heart assist device in the United States.
Mr Rohrbaugh further commented that "many therapies receive feedback requiring consultation with the FDA, and we look forward to meeting with them later this month to address their comments. Once our IDE application is approved, we expect that the feasibility trial will enable Sunshine Heart to provide this unique therapy to moderate heart failure patients who represent a significant unmet clinical need."