Technology | December 14, 2011

New Aortic Aneurysm Repair Technology From Aptus Cleared by FDA


December 14, 2011 — Aptus Endosystems Inc. announced it received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Aptus EndoStapling System, which will now be known as the HeliFX Aortic Securement System. Aptus develops technology for endovascular aneurysm repair (EVAR). 

The innovative helical anchor technology enables independent endograft fixation, and is designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms (AAA). Aortic aneurysms are an enlarged and weakened section of the aorta, the main artery carrying blood from the heart, which can be lethal if left untreated. 

Each year, an estimated 200,000 people in the United States and 100,000 people in Europe are diagnosed with AAA. In EVAR — an alternative to open surgical repair of AAA — 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 HeliFX System provides physicians with a novel technology to repair endovascular grafts that have migrated away from the implant site or have developed endoleaks. The system is also indicated for those at risk of developing these complications, which are commonly seen after EVAR. In such cases, augmented fixation and/or sealing is required to regain or maintain effective aneurysm exclusion. The system also can be used during de novo (initial) EVAR procedures to enhance an endograft’s inherent fixation and sealing mechanisms. 

“Long-term failure is arguably the primary impediment to defining EVAR as the new gold standard in aortic aneurysm treatment,” said David Deaton, M.D., associate professor of surgery and chief, vascular and endovascular surgery, Georgetown University Hospital, Washington, D.C.  “The ability to achieve the physical equivalent of hand-sewn, open surgical repair with the HeliFX system represents not only a fundamentally new endovascular capability, but a possible solution to the vexing problem of late migration and proximal neck dilation that are major causes of late EVAR failure and aneurysm rupture.”

“The HeliFX system is a leap forward in EVAR technology,” said Manish Mehta, M.D., associate professor of surgery, Albany Medical Center, Albany, N.Y.  “The system has applications in preventing as well as managing stent graft migration and type 1 endoleaks. It truly is a new advancement that gives us the ability for precise placement of anchors that attach the stent graft to the aortic wall and enhance fixation, particularly in short and/or angulated aortic necks.”

The system received CE Mark for use in the European Union in May of this year. Approval in the United States allows HeliFX to be used with Cook Zenith, Gore Excluder, and Medtronic AneuRx, Endurant, and Talent endografts in both initial implant and secondary repair settings.  Use with other endografts has not been evaluated to date.

For more information: www.aptusendosystems.com

Related Content

News | Endovascular Aortic Repair

May 12, 2021 — Preliminary results of a clinical trial, presented today at the AATS 101st Annual Meeting, showed that a ...

Home May 12, 2021
Home
News | Endovascular Aortic Repair

February 23, 2021 — Medtronic has voluntarily issued a global recall of unused Medtronic Valiant Navion thoracic stent ...

Home February 23, 2021
Home
News | Endovascular Aortic Repair

January 31, 2020 – The Society for Vascular Surgery (SVS) and Society of Thoracic Surgeons (STS) released new reporting ...

Home January 31, 2020
Home
News | Endovascular Aortic Repair

January 29, 2020 – The presence of a blood clot on the wall of the aorta in people with abdominal aortic aneurysms (AAA) ...

Home January 29, 2020
Home
News | Endovascular Aortic Repair

November 7, 2019 — The Endospan Ltd. Nexus aortic arch stent graft is a CE mark–approved, off-the-shelf system for ...

Home November 11, 2019
Home
News | Endovascular Aortic Repair

November 21, 2018 — New research in the December edition of the Journal of Vascular Surgery suggests significant ...

Home November 21, 2018
Home
News | Endovascular Aortic Repair

October 8, 2018 — Endologix Inc. received notice that the U.S. Food and Drug Administration (FDA) has classified a ...

Home October 08, 2018
Home
Feature | Endovascular Aortic Repair | Andrei Churyla, M.D., S. Chris Malaisrie, M.D.

Here are several considerations for physicians when choosing endovascular stent grafts used to treat aortic aneurysms ...

Home February 05, 2018
Home
News | Endovascular Aortic Repair

October 19, 2017 — Endologix Inc. received Investigational Device Exemption (IDE) approval from the U.S. Food and Drug ...

Home October 19, 2017
Home
News | Endovascular Aortic Repair

May 23, 2017 — Significant success has been achieved in treating complex proximal aneurysms using a combination of ...

Home May 23, 2017
Home
Subscribe Now