SUNNYVALE, Calif.--(EON: Enhanced Online News)--Aptus Endosystems, Inc., a medical device company pioneering solutions to enhance aneurysm repair, today announced positive initial results from its ANCHOR post-market registry evaluating the use of the Heli-FX™ EndoAnchor System in endovascular aneurysm repair (EVAR). Heli-FX is a mechanical fastening device that connects the endograft to the aorta and is designed to enhance the long-term durability of the procedure and reduce the risk of repeat interventions in EVAR. These early results from the first 250 patients demonstrate the safety and acute technical success of utilizing Heli-FX in primary and revision EVAR procedures. These data were presented for the first time by James Joye, D.O., interventional cardiologist at El Camino Hospital, at the 11th VIVA conference held in Las Vegas, Nevada on October 8–11, 2013.
“The ANCHOR registry has been enrolling fast thanks to strong support from our physicians, and we are pleased to share these initial, early results”
“EVAR has become the standard of care in aneurysm repair despite shortcomings in long-term durability resulting from issues often encountered in maintaining proper sealing and fixation of an endograft to the aorta, especially in challenging anatomies,” said Dr. Joye. “These initial ANCHOR results show the potential for a definitive solution to a long-standing limitation in EVAR. Further study and long-term data will determine if Heli-FX is able to reduce aneurysm-related adverse events, reduce the need for secondary interventions, and will assess the need for long-term follow-up.”
ANCHOR (Aneurysm Treatment Using the Heli-FX™ Aortic Securement System Global Registry), a global, multicenter, prospective post-market registry, evaluates the use of the Heli-FX system in EVAR and captures critical data on the use of the technology as well as acute and long-term procedural outcomes. Initial results from the registry showed:
- Acute safety and efficacy results with Heli-FX;
- Heli-FX is used in conjunction with a variety of endografts and in both primary and revision EVAR procedures, with primary prophylactic use outweighing revision cases by approximately three to one;
- Heli-FX was used in revision procedures to repair Type 1 endoleaks or endograft migration in patients with previously placed endografts with 91% acute technical success.
“The ANCHOR registry has been enrolling fast thanks to strong support from our physicians, and we are pleased to share these initial, early results,” said James Reinstein, president and CEO of Aptus Endosystems, Inc. “Especially interesting has been the high percentage of patients who have received Heli-FX prophylactically, showing that in the real world setting, physicians are concerned with the long term results of patients who have difficult proximal neck anatomy.”
About the Heli-FX EndoAnchor System
The Heli-FX EndoAnchor System is a mechanical fastening device that is designed to enhance the long-term durability and reduce the risk of repeat interventions in EVAR. By deploying small helical screws to connect the graft to the aorta, Heli-FX seeks to provide a permanent seal and fixation, similar to the stability achieved in an open surgical anastomosis. The Heli-FX system can be used during primary EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms. It can also be used to repair endovascular grafts that have developed endoleaks, migrated away from the implant site, or are at risk of developing these complications, which are often seen after EVAR.
About Aortic Aneurysms
An aortic aneurysm is an enlarged and weakened section of the aorta (the main artery carrying blood from the heart) that can be life-threatening if left untreated. There are two common types of aortic aneurysms, abdominal aortic aneurysms (AAA) and thoracic aortic aneurysms (TAA). An estimated 1.5 million Americans have AAA, and an estimated 200,000 people in the U.S. and 100,000 people in Europe are diagnosed with AAA each year. In EVAR and thoracic endovascular aneurysm repair (TEVAR), an alternative to open surgical repair of aortic aneurysms, a minimally invasive catheter-based system is used to implant a metal and fabric endograft to isolate blood flow away from the aneurysm to prevent potential rupture and death. The innovative helical anchor technology of the Heli-FX system enables independent endograft fixation and sealing and is designed to replicate hand suturing performed during open surgical repair of aneurysms.
About VIVA Physicians
VIVA Physicians is a not-for-profit organization dedicated to advancing the field of vascular medicine and intervention through education and research. VIVA's mission is demonstrated through activities such as supporting a multidisciplinary fellowship, collaborating with international vascular symposia, interacting with policy makers, and supporting and contributing to philanthropy. Since 2003, VIVA Physicians has sponsored an annual symposium in Las Vegas, Nevada where recognized experts from around the world come to share the latest research, learn about innovative technologies and therapies for vascular disease, and discuss the latest efforts to improve vascular patient care. To learn more about VIVA Physicians visit http://www.vivapvd.com. You can also connect with VIVA Physicians on Facebook, Twitter and LinkedIn.
About Aptus Endosystems, Inc.
Aptus Endosystems is a privately held, Sunnyvale, California-based medical device company that is pioneering solutions to enhance aneurysm repair. Aptus is focused on improving long-term outcomes and quality of life for patients undergoing EVAR and TEVAR procedures. Aptus has developed a unique helical anchor technology that allows physicians to perform minimally invasive aneurysm repair while still providing the control and potential long-term durability of an open surgical repair. Aptus has successfully designed and brought to market two endograft anchoring systems that are currently being used in EVAR and TEVAR procedures in the United States and Europe—the Heli-FX EndoAnchor System and the Heli-FX Thoracic EndoAnchor System. For more information, please visit www.aptusendosystems.com.