The Endurance randomized, controlled, multi-center trial will meet its primary endpoint with 2 years of follow-up, with subsequent follow-up extending to 5 years. The company plans to ask FDA permission to extend the trial to additional patients through the federal watchdog agency’s "continued access protocol" pathway.
HeartWare researchers hope to find patients alive and without debilitating strokes, having survived long enough to receive a heart transplant or having recovered and no longer needing the device, according to a press release.
"Completing enrollment in this, the largest head-to-head ventricular assist device clinical trial to date, is a major achievement and we look forward to following this destination therapy patient population to primary endpoint over the next 2 years," HeartWare president & CEO Doug Godshall said in prepared remarks. "With enrollment of the study complete, we are pleased to report that more than 2,000 end stage heart failure patients globally have received the HeartWare ventricular assist system."
The HeartWare HVAD is currently also under FDA review as a bridge-to-transplant therapy for advanced heart failure patients. An FDA expert advisory panel late last month recommended approval for the HVAD implantable heart pump for people with end-stage heart failure.
Angels in America – 2011 was a good year for investment
An analysis finds that angel investment in 2011 was 40% higher than in 2010. Furthermore, nearly 30% of funding was invested in California, nearly 60% went to internet and health care groups, and 60% of health care investment was in medical device and equipment makers. Read more
Bayer considers ditching diabetes business
Drug giant Bayer (PINK:BAYRY) may ditch its diabetes devices arm, which posts annual sales of about $1.3 billion (€1 billion), anonymous sources told Reuters. Read more
iCad gets a stay of execution from Nasdaq delisting
iCad (NSDQ:ICAD) received notice from the Nasdaq stock exchange that the company has an additional 180 days to boost it’s stock value up past the $1 mark for 10 consecutive days or face delisting. ICAD shares were trading around 45¢ as of about 3:15 p.m. today. Read more
INC Research expands a electronic data management partnership with Medidata
INC Research extended its electronic data capture and clinical data management partnership with Medidata NSDQ:MDSO) by landing 3 new accreditations and launching services with its Medidata Balance, Rave Targeted SDV and Coder platforms. Read more
GPOs: Kimberly Clark renews a sterilization wrap contract with HealthTrust
Kimberly-Clark (NYSE:KMB) renewed a contract with group purchasing organization HealthTrust Purchasing Group to supply Kimguard single- and double-ply sterilization wraps. The new 3-year agreement is effective June 1. Read more
- EndoSphere raises $3.1M of a hoped-for $5M equity funding round
- Micro Interventional Devices lands $500k bridge financing to support clinical trials of Permaseal “self-sealing” cardiac access closure device
- Stereotaxis announces a private placement offering of 21.7M shares of common stock in a sale worth $9.2M