Innovative AAA Device Offers New, Less Invasive Option for Patients and Physicians
FREMONT, Calif - Wednesday, September 10th 2014 [ME NewsWire]
(BUSINESS
WIRE)-- Cordis Corporation announced today the launch of its INCRAFT®
AAA Stent Graft System (INCRAFT® System), an ultra-low profile device
for use during endovascular aneurysm repair (EVAR) for patients
suffering from infrarenal abdominal aortic aneurysms (AAA). The INCRAFT®
System is cleared for use and now available in Europe and Canada. This
device is an advancement in the EVAR field and provides a new option for
patients and physicians seeking a less invasive treatment approach for
AAA.
An estimated 24 million people worldwide suffer from AAA, an
abnormal enlargement of the large blood vessel (aorta) that supplies
blood to the abdomen, pelvis and legs. Left untreated, all aneurysms
will eventually rupture and the majority of ruptured aneurysms result in
death.
The INCRAFT® System is intended for the endovascular
treatment of patients with infrarenal AAA. The INCRAFT® System, which
features an ultra-low profile endovascular stent graft system with
innovative technology designed for durability, conformability and
sealing without the need for polymers, is intended to reinforce the
lower part of the aorta to prevent an aneurysm from rupturing. The
INCRAFT® System is the lowest profile EVAR system now available in
Europe and Canada with a 14 French (F) outer diameter, including the
integrated sheath, which is equivalent to a 12F catheter sheath
introducer profile*. Most EVAR stent grafts have a system profile
ranging from 16F to 22F in size.
This ultra-low profile device is
designed for proximal and distal placement accuracy and allows for
customization during the procedure to accommodate a wide range of
anatomical sizes. This broad anatomical coverage is offered with a
minimal number of product codes for easier pre-procedural planning.
“The
INCRAFT® System is an attractive new EVAR device option because its
ultra-low profile design and customization allows physicians to consider
this less invasive procedure for many patients, especially those with
smaller vasculature who might otherwise be ineligible for EVAR,” said
Prof. Giovanni Torsello, MD, of the St. Franziskus Hospital Münster in
Germany. “The recently published two-year data on the INCRAFT® System
from the INNOVATION Trial in Europe demonstrated excellent performance
adding to the scientific data supporting the device.”
The INNOVATION
Trial is a multicenter, open-label, prospective, non-randomized study
designed to assess the safety and performance of the device in the
treatment of patients with AAA with investigational sites in Germany and
Italy. At two years, results from the study demonstrated the device
performed well in patients and showed no incidences of aneurysm
enlargement, endoleaks (type I, or III), device or procedure related
major adverse events, stent-graft migrations or stent fractures. One
patient in the study developed a late graft occlusion unrelated to the
device that was caused by shrinkage of the aneurysm. The two-year study
results were presented at the 2014 Charing Cross Symposium and
subsequently published in the July 2014 online issue of the Journal of
Vascular Surgery.1
“With the launch of the INCRAFT® System, Cordis is
bringing an innovative advancement to the field of EVAR, while entering
a growth segment that further diversifies our strong product
portfolio,” said Celine Martin, Worldwide President, Cordis Corporation.
“At Cordis, we are proud to deliver market-relevant interventional
vascular treatments to address unmet needs, and with the availability of
the INCRAFT® System, more patients will have access to an important,
new EVAR treatment option.”
The INCRAFT® System is currently approved
for investigational device use only in the U.S. and Japan and is being
studied in a global pivotal clinical study in the U.S. and Japan called
the INSPIRATION Trial, which completed enrollment in 2013.
About Abdominal Aortic Aneurysms (AAA) and Endovascular Aortic Repair
While
the cause is not well-known, an aneurysm may develop in the lower part
of the aorta and cause it to weaken as it enlarges or bulges. As the
aorta is the largest blood vessel in the body and main supplier of blood
to the body, a damaged or ruptured AAA can cause life-threatening
bleeding. Most patients with AAA do not experience any noticeable
symptoms and is why AAA is commonly referred to as the “silent killer.”
EVAR is a minimally invasive alternative to open surgery for the repair
of an AAA. The procedure involves the placement of a stent graft into
the aneurysm through a small incision in the groin to prevent the
aneurysm from rupturing.
About Cordis Corporation
Cordis
Corporation, part of the Johnson & Johnson Family of Companies, is a
worldwide leader in the development and manufacture of interventional
vascular technology. Through the company's innovation, research and
development, Cordis partners with experts worldwide to treat millions of
patients who suffer from vascular disease. More information can be
found at www.cordis.com or in product labeling.
1J Vasc Surg. 2014 Jul 19. pii: S0741-5214(14)01118-5. doi: 10.1016/j.jvs.2014.06.007. [Epub ahead of print]
*16F outer diameter for the 34 mm aortic bifurcate.
(This
press release contains "forward-looking statements" as defined in the
Private Securities Litigation Reform Act of 1995, including expectations
related to the INCRAFT® AAA Stent Graft System. The reader is cautioned
not to rely on these forward-looking statements. These statements are
based on current expectations of future events. If underlying
assumptions prove inaccurate or known or unknown risks or uncertainties
materialize, actual results could vary materially from the expectations
and projections of Cordis Corporation and/or Johnson & Johnson.
Risks and uncertainties include, but are not limited to: manufacturing
difficulties and delays, internally or within the supply chain;
challenges to patents; changes in behavior and spending patterns or
financial distress of purchasers of health care products and services;
changes to governmental laws and regulations and domestic and foreign
health care reforms; and general industry conditions, including trends
toward health care cost containment. A further list and description of
these risks, uncertainties and other factors can be found in Johnson
& Johnson’s Annual Report on Form 10-K for the fiscal year ended
December 29, 2013, including in Exhibit 99 thereto, and the company’s
subsequent filings with the Securities and Exchange Commission. Copies
of these filings are available online at www.sec.gov, www.jnj.com or on
request from Johnson & Johnson. Neither Cordis Corporation nor
Johnson & Johnson undertakes to update any forward-looking statement
as a result of new information or future events or developments).
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Contacts
Press Contacts:
Janet Graesser, 650-687-4809
650-464-5497 (mobile)
jgraesse@its.jnj.com
Janet Kim, 909-839-7275
213-215-5737 (mobile)
jkim50@its.jnj.com
Investor Contacts:
Louise Mehrotra, 732-524-6491
lmehrot@its.jnj.com
Sue Hohenleitner, 732-524-3709
Shohen1@its.jnj.com
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