|CryoLife Receives FDA Clearance For Next Generation HeRO Device; Aastrom Enrollls First Patients in ixCELL-DCM|
|By Staff and Wire Reports|
|Thursday, 04 April 2013 18:36|
CryoLife (NYSE: CRY), a leading tissue processing and medical device company focused on cardiac and vascular surgery, announced it has received U.S. FDA 510(k) clearance for a next generation HeRO (Hemodialysis Reliable Outflow) device. The HeRO device is the only subcutaneous AV access solution clinically proven to maintain long-term access for end-stage renal disease (ERSD) hemodialysis patients with central venous stenosis. CryoLife anticipates launching the next generation HeRO device during the fourth quarter of 2013 following scale up and validation of the manufacturing process.
The newly cleared version features an adaptor that provides the option to pair the HeRO device's proprietary venous outflow component with certain other available dialysis access grafts, including early access arterial grafts. The current generation includes a standard ePTFE graft, which requires the placement of a temporary dialysis catheter for approximately 2-3 weeks until the graft incorporates into the surrounding tissue and can be used for hemodialysis access. By design, early access grafts allow access in a matter of days, thus eliminating the need for an accompanying dialysis catheter.
"We are pleased to receive FDA clearance for our next generation HeRO device, which will provide our customers with the option of using a standard or early access arterial graft in conjunction with the device's proprietary venous outflow component," noted Steven G. Anderson, chairman, president and CEO of CryoLife. "Early access grafts eliminate the need for temporary dialysis catheters, which are associated with increased risk of infection, further enhancing the clinical benefits of the HeRO device. Over the next several months we will work to optimize and validate the manufacturing processes for this next generation system, which includes scaling up our manufacturing supply chain."
Aastrom Biosciences, Inc. (Nasdaq: ASTM), the leading developer of patient-specific expanded multicellular therapies for the treatment of severe chronic cardiovascular diseases, announced the first patients have been enrolled in the ixCELL-DCM clinical trial. This Phase 2b study is currently underway in the United States to assess the efficacy and safety of ixmyelocel-T in the treatment of patients with advanced heart failure due to ischemic dilated cardiomyopathy (ischemic DCM).
The ixCELL-DCM trial is a randomized, double-blind, placebo-controlled phase 2b study with a planned enrollment of 108 patients at approximately 30 sites in the U.S. In the study, ixmyelocel-T will be administered via catheter-based injections to patients with advanced heart failure due to ischemic DCM. The primary endpoint of the trial will be the average number of events per patient, which include all-cause mortality, all-cause hospitalizations or unplanned hospital visits to treat worsening heart failure. Patients will be followed for a total of 12 months.
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