SUNNYVALE, Calif.–(BUSINESS WIRE)–Aptus Endosystems Inc.,
a medical device company developing advanced technology for endovascular
aneurysm repair (EVAR), announced the successful treatment of the first series
of patients in the United
States with the HeliFXTM Aortic Securement
System after having received FDA clearance on Nov. 21. The innovative helical
anchor technology enables independent endograft fixation to the aorta, and is
designed to mimic the hand suturing performed during open surgical repair of abdominal aortic aneurysms (AAAs). In the first few weeks
since regulatory clearance, physicians have already used the HeliFX System in
both de novo (initial) EVAR procedures as well as in secondary interventions,
and with several different manufacturers endografts – all in cases where the
physicians believed that long term patient outcomes would be improved with
augmented fixation and sealing of the endograft with the HeliFX EndoAnchorsTM.
“Technology such as the HeliFX System has long been
overdue,” said Venkatesh Ramaiah, MD, Director of Peripheral Vascular Surgery
and Endovascular Research at the Arizona Heart Institute, Phoenix, who performed one of the first
procedures. “We are often faced with high surgical risk patients with
challenging anatomy who require improved fixation and sealing for long term durability.
I found the EndoAnchor deployment to be easy and highly accurate despite
difficult anatomy. We were able to treat an angulated and conical proximal
neck, and also correct an intra-operative Type 1 endoleak – all in a patient
who had limited treatment alternatives.”
“It was great to be able to use the HeliFX EndoAnchors,”
said William Jordan, MD, Chief, Section of Vascular Surgery at the University
of Alabama Hospital, Birmingham,
who performed the procedure on two patients. “This advance offers us a means to
securely fix aortic endografts when treating anatomically challenging patients.
Its the right technology at the right time.”
“The HeliFX System is a game-changing technology that
will allow us to safely and effectively offer stent graft therapy to a much
broader population of patients,” said James Joye, DO, Director of Research,
Education, and Interventional Services at the Heart & Vascular Institute of
El Camino Hospital in Mountain View,
California. “In our first
application of this intuitive device we were able to treat a patient with a
short, angulated infrarenal neck who otherwise was bound for open surgical
repair. The EndoAnchor resolved a Type I endoleak immediately, and left me with
the security and confidence that I would not have to worry about endograft
migration in the years to come”.
“Completing our first series of HeliFX cases in the United
States marks the beginning of a new chapter for EVAR, and we are privileged to
work with well-regarded thought leaders such as Drs. Ramaiah, Jordan, Joye, and
others,” said Jeff Elkins, CEO of Aptus Endosystems, Inc. “This initial US
experience supports the ease of use and procedural success that we have seen
with the HeliFX System in Europe. The novel concept of independent and
physician-controlled proximal fixation using EndoAnchors represents a
considerable step toward addressing and preventing long-term complications and
making EVAR the definitive solution for treating aortic aneurysms.”
About Aptus Endosystems, Inc.
Headquartered in Sunnyvale,
Calif., Aptus Endosystems is a
privately held medical device company focused on developing advanced technology
for endovascular aneurysm repair (EVAR). An estimated 1.5
million Americans have an abdominal aortic aneurysm (AAA), which can be
life-threatening if left untreated and approximately 200,000 people are newly
diagnosed each year. Aptus Endosystems has developed a unique endograft and innovative helical anchor technology that allows physicians
to perform minimally invasive EVAR while still providing the control and
potential long term durability of an open surgical repair. The FortevoTM AAA
Endograft System and the HeliFX Aortic Securement System bear the CE Mark for distribution
in the European Union. The HeliFX Aortic Securement System is cleared by the
FDA for distribution in the United
States. The Fortevo AAA Endograft System is
Investigational Use Only in the United
States. For more information, please visit www.aptusendosystems.com
Posted by Sean Fenske, Editor-in-Chief, MDT