HOME >> MEDICINE >> NEWS
VCR -- FDA approves home discharge for US patients

SYDNEY Australia, 17 November 2006 -- Ventracor (ASX:VCR) today announced that the US Food & Drug Administration (FDA) has approved the company's request to allow home discharge of patients implanted with the VentrAssist under the US Feasibility Trial.

Chief Executive Officer Peter Crosby said: "Until now, US VentrAssist patients have been required to remain in hospital or an intermediate care facility until heart transplant.

"Removing this requirement makes participation in the US Feasibility Trial more attractive to patients because they are able to return to their home once they are discharged by their physician."

"We expect this approval will be a catalyst for recruitment in coming weeks, and is a key step on the path towards meeting our previously announced milestone of commencement of enrolment in the US Bridge To Transplant (BTT) Pivotal Trial in early 2007," Mr Crosby said.

The FDA approval is conditional on the company making amendments to the labeling of the VentrAssist within 45 days, however the ability for patients to be discharged home is immediate.


'"/>

Contact: Andrew Geddes
info@ventracor.com
61-294-063-086
Research Australia
17-Nov-2006


Page: 1

Related medicine news :

1. DFG approves 11 new Collaborative Research Centers
2. FDA approves ZYFLO CR extended-release tablets for chronic treatment of asthma
3. FDA approves Dey, L.P.s Perforomist inhalation solution for maintenance treatment of COPD
4. FDA approves prescription Zaditor for over-the-counter relief from itchy eyes
5. FDA approves Vectibix to treat patients with metastatic colorectal cancer
6. 5,000 rare diseases need drugs, but Europe only approves a handful each year
7. FDA approves room temperature storage of ZLB Behrings Helixate FS
8. FDA approves new indication for Topamax as initial monotherapy for adults and children with epilepsy
9. FDA approves first blood test to predict risk for stroke
10. FDA approves Boostrix a new US vaccine for adolescents against pertussis
11. Postpartum hospital discharges -- when is the right time?

Post Your Comments:
*Name:
*Comment:
*Email:


(Date:3/30/2021)... , ... March 29, 2021 , ... ... the 21st Century , A Virtual Workshop Presented by WCG FDAnews and Cerulean ... 4:30 pm EDT, https://wcg.swoogo.com/modern-sop-and-quality-systems , Are one’s SOPs written for the ...
(Date:3/30/2021)... ... March 29, 2021 , ... According to data released ... reproductive age (13-44) in need of publicly funded contraception live in counties impacted by ... Colorado’s 64 counties have lost some of their Title X resources. , The ...
(Date:3/30/2021)... ... March 29, 2021 , ... Health Literacy Innovations (HLI), a ... confusion due to low health literacy today announces a new partnership with the ... work with ACAP’s member Safety Net Health Plans, those that provide comprehensive health ...
(Date:3/30/2021)... ... ... Dr. Colin Campbell is proud to announce the 1 year anniversary in their new state ... internal medicine and is a primary care specialist who has been practicing for 23 years. ... keep South Jersey healthy one patient at a time. , “Over the past year, Dr. ...
(Date:3/30/2021)... ... March 30, 2021 , ... The COVID-19 ... and survivors; their families; and their caregivers. Crossroads4Hope is addressing the needs of ... emotional support system, MyGo2Support, which meets needs of people impacted by cancer, no ...
Breaking Medicine News(10 mins):
(Date:3/30/2021)... ... March 29, 2021 , ... The University of Texas Health Science Center ... San Antonio Multispecialty and Research Hospital, a destination center for research and treatment of ... In a nod to the COVID-19 pandemic, the ceremony was held virtually. , William ...
(Date:3/30/2021)... ... March 29, 2021 , ... Iora Health ... primary care, has partnered with Devoted Health , one of the fastest-growing ... across Maricopa County and provides seniors with the highest-quality care and experience possible, ...
(Date:3/30/2021)... CITY (PRWEB) , ... March 29, 2021 , ... ... has joined the Vaccine Credential Initiative (VCI), a group bringing together leading health ... record of vaccination status, based on open, interoperable standards. By joining the VCI ...
Breaking Medicine Technology:
Cached News: