Aptus Endosystems, Inc., a medical device company developing advanced
technology for endovascular aneurysm repair (EVAR), announced today that
it received 510(k) clearance from the U.S. Food and Drug Administration
(FDA) for its thoracic-length HeliFXTM Aortic Securement
System. Similar to the original HeliFX system that was cleared in
November 2011 and designed for treating abdominal aortic aneurysms
(AAA), the new system consists of a longer delivery device with
additional tip configurations to bring the innovative helical EndoAnchorTM
technology to the treatment of thoracic aortic aneurysms (TAA).
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. It is estimated that 60,000 people in the U.S. may have a
TAA. In thoracic endovascular aneurysm repair (TEVAR), an alternative to
open surgical repair of TAA, 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.
Complications can arise from TEVAR if the implanted endograft migrates
(loses position) or does not result in a seal with the vessel wall
(endoleak) to effectively isolate the aneurysm.
The new HeliFX System allows physicians to deliver Aptus' novel
EndoAnchor technology to the thoracic aortic anatomy. The implantable
EndoAnchor enables independent endograft fixation, and is designed to
replicate the sealing and fixation of hand suturing performed during
open surgical repair of aortic aneurysms. It can be used during de
novo (initial) TEVAR procedures to enhance an endograft's inherent
fixation and sealing mechanisms. In addition, the EndoAnchors can be
used to repair endovascular grafts that have migrated away from the
implant site and have developed endoleaks or are at risk of developing
these complications. In such cases, augmented fixation and/or sealing is
required to regain or maintain effective aneurysm exclusion.
"Complications from TEVAR such as endograft migration and endoleaks are
even more critical in this patient population given the high surgical
morbidity and mortality rates," said Michael Dake, M.D., Professor of
Cardiothoracic Surgery at Stanford University School of Medicine,
Stanford, Calif. "The HeliFX system offers physicians a new endovascular
capability to improve fixation and sealing of TEVAR endografts and
potentially improve procedural durability for patients."