REDWOOD CITY, Calif., Dec. 1, 2011 /PRNewswire/ -- Clinical Investigators for Arstasis, Inc., reported the results of the RECITAL study during the recent TCT Meeting in San Francisco, demonstrating the Arstasis access device enables rapid, secure, implant-free closure of femoral arteries after cardiac catheterization procedures. The device creates a unique access pathway, called an Arstaotomy, into the femoral artery through which catheterization procedures are performed.
RECITAL is a prospective, multi-center clinical study that enrolled 351 patients to assess device and procedural success of key post-catheterization recovery measures that influence the safety and speed toward discharging those patients from the hospital. The results indicate that hospitals may be able to both reduce current complication rates and eliminate costs from longer hospitalizations in this patient population.
Key results of the RECITAL study showed that device deployment was successful in 97% of RECITAL patients and femoral bleeding stopped after only 3 minutes for diagnostic angiogram patients and 5 minutes for anti-coagulated patients undergoing a percutaneous coronary intervention (PCI). Most of the patients were able to sit up within 15-30 minutes and were able to walk in about one hour after an angiogram and two hours after a PCI. Investigators found no major complications related to use of the Arstasis device.
Dr. Dale Wortham, University of Tennessee Medical Center, Knoxville and RECITAL Study Principal Investigator, commented, "Introducing foreign materials in a patient to close the femoral artery can be problematic. We were very pleased the RECITAL Study demonstrated the Arstaotomy procedure can deliver closure-like hemostasis and ambulation times without the use of a temporary or permanent implant."
The RECITAL Study illustrates the Arstaotomy procedure can potentially accelerate patient throughput, delivering a quicker, more comfortable experience for the patient while reducing hospital resource use and overall cost per patient.
Separately, Arstasis announced the appointment of David I. Bruce to the position of President and CEO. The company's founder, Bruce Modesitt, who has been CEO since its inception in 2004, will focus on expanding the product platform as Chief Technology Officer.
"At this point in our company's history, we're delighted to attract a seasoned CEO with repeat successes in managing early market penetration for novel medical devices," commented Bruce Modesitt, "and I look forward to David's leadership in accelerating our business growth."
New CEO David Bruce said, "I'm pleased to be joining the Arstasis team as we announce the results of our first U.S. clinical trial. RECITAL demonstrates the Arstaotomy procedure helps minimize complications, speed recovery and enable earlier discharge. With our investigators and initial customers showing outstanding results, we are positioned to achieve broader adoption into the ten million arterial catheterization procedures performed worldwide each year."
The AXERA Access Device is a breakthrough femoral artery access tool that quickly creates a long, ultra-low angle arteriotomy, the Arstaotomy, resulting in significant tissue-upon-tissue overlap in the artery wall. The Arstaotomy procedure requires minimal manual compression to provide secure arterial closure with no foreign body implants thereby eliminating the risk of infections and thromboembolic events related to vascular implants.
Arstasis, Inc. is headquartered in Redwood City, CA. Additional information about the RECITAL Study, Arstaotomy procedure and AXERA Access Device is available at www.arstasis.com.
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SOURCE Arstasis, Inc.