Arstasis

Arstasis, a medical device company founded in 2004 by D. Bruce Modesitt, focused on developing solutions for arterial closure following catheterization procedures. The company operated from Redwood City, California, and is now considered deadpooled. David Bruce, a veteran executive from Siemens Medical, joined as President and CEO in November 2011. The firm's core business was centered on the development and sale of vascular access devices to hospitals and catheterization labs, aiming to improve upon the long-standing Modified Seldinger Technique.

The company's main product was the AXERA Access Device, also known as the Arstasis One Access System. This device was engineered to create a longer, shallower-angled entry into the femoral artery, called an "Arstaotomy." The benefit of this approach was that upon removal of the procedural sheath, the artery's natural blood pressure would cause the tissue layers to overlap and seal the opening, requiring only minimal manual compression. This method was designed to achieve rapid hemostasis without leaving a foreign body implant, thereby reducing risks of infection and thromboembolic events associated with traditional closure devices. For patients, this translated to quicker ambulation and shorter bed rest times.

Throughout its operation, Arstasis secured significant capital, raising a total of $102 million over four funding rounds. Notable funding events include a $25.5 million round in June 2011 and a subsequent round of $37.8 million in June 2012. The company received FDA 510(k) clearance for its Arstasis One system in May 2010. However, it also faced challenges, including a Class I FDA recall in February 2011 for its One Access system due to reports of device components potentially separating during procedures.

Keywords: Arstasis, vascular closure, femoral artery access, AXERA Access Device, Arstaotomy, medical device, catheterization, hemostasis, Modified Seldinger Technique, arterial closure, implant-free closure, vascular access, interventional cardiology, Redwood City, D. Bruce Modesitt, David Bruce, Arstasis One, surgical devices, cardiovascular procedures