Nationwide Launch of Arstasis One Access Device Provides Cath Labs Across the U.S. an Alternative to Standard Arteriotomies and Vascular Closure Implants
REDWOOD CITY, Calif., Jan. 4, 2011 /PRNewswire/ -- Arstasis is pleased to announce the Arstasis One Access Device is available to physicians, nurses, patients, and cath lab technicians across the United States. Until now, only a select number of physicians participating in Arstasis clinical trials and select pre-launch registries have been able to use the device. As of today, the company is making the simple-to-use, disposable tool that allows physicians to perform the Arstaotomy procedure available to any qualified U.S. hospital with an accredited cardiac catheterization laboratory.
"We are delighted to begin providing U.S. cardiologists with a femoral artery access device that allows them to perform angiography without resorting to inserting a vascular closure implant into the patient," said Bruce Modesitt, CEO of Arstasis.
Along with the U.S. launch, patient enrollment is continuing in the RECITAL (A Patient Registry Evaluating Closure Following Access with the Arstasis One Access Device) study, a non-randomized, prospective, post-market registry anticipated to enroll up to 500 patients in at least seven U.S. hospitals.
Since 1959, physicians have been using the Modified Seldinger Technique to insert flexible catheters into the femoral artery of patients for the purpose of performing procedures in the patient's arterial-vascular system. The most prevalent such procedure, diagnostic angiography, is thought to be performed more than half a million times per month worldwide. At the end of every such case, each patient is left with a substantial hole in his/her femoral artery (upper inner thigh) which typically takes significant effort and cath lab resources to close. With the Arstasis One Access Device, however, physicians create a shallow-angle needle pathway through the wall of the femoral artery. At the end of the procedure, when the sheath is withdrawn, the shallow-angle pathway collapses from the norm