This article was originally published in The Gray Sheet
Severe abdominal bleeding unrelated to the firm's AbioCor artificial heart caused the death of the first device recipient Nov. 30 after 151 days of use as part of an ongoing U.S. clinical trial, the firm states. Previous anticoagulant treatment also contributed to the death of the sixth AbioCor recipient from uncontrolled bleeding on Nov. 28. FDA cleared expansion of the trial from five to 10 patients on Nov. 26. Under the original IDE agreement, the U.S. AbioCor trial is expected to include three groups of five patients. The company expects to file a PMA in 2003...
You may also be interested in...
Abiomed is developing a smaller version of its artificial heart for the 65% of patients whose chest size is not large enough to accommodate the AbioCor device. The company recently began testing the Penn State Heart in animals and expectshuman implants to begin in 2004
Trademarks are registered and published for opposition with the US Patent and Trademark Office and are published weekly in the agency's Official Gazette.
Japanese ICT giant applies novel advanced computing techniques with a US venture partner to more rapidly identify lead molecules from a huge virtual space.