Abbott's XIENCE PRIME(TM) Receives CE Mark for Treatment of Most Advanced Form of Arterial Disease in the Lower LegBy Abbott, PRNE
Wednesday, January 19, 2011
Positive Results of DESTINY Trial Supported CE Mark for XIENCE PRIME for the Treatment of Critical Limb Ischemia or Severe Claudication (Pain) of the Lower Leg
BRUSSELS, January 20, 2011 - Abbott announced today that it has received CE Mark for its XIENCE
PRIME(TM) Everolimus Eluting Coronary Stent System for the treatment of
critical limb ischemia (CLI) or severe claudication (pain) of the lower leg.
CLI is the most advanced form of peripheral artery disease (PAD) that can
ultimately lead to limb amputation. With this expanded indication, XIENCE
PRIME can be marketed to treat CLI or severe claudication of the lower leg in
European Union countries and others that recognize CE Mark.
"Abbott's XIENCE PRIME drug eluting stent is used by physicians
throughout Europe as a key option for treating coronary artery disease, and
Abbott is pleased to bring the excellent attributes of XIENCE PRIME to
European patients suffering from advanced artery disease of the lower leg,"
said Robert Hance, senior vice president, vascular, Abbott. "Treating a
diseased vessel in the lower leg with an everolimus eluting stent has
generated compelling clinical data compared to treatment with a bare metal
stent, and we are confident that XIENCE PRIME will become an important option
for European physicians treating this critical disease."
The CE Mark for XIENCE PRIME to treat CLI or severe claudication of the
lower leg is supported by the data generated on the company's XIENCE V(R)
drug eluting stent from the DESTINY trial. A 140-patient,
investigator-sponsored, randomized, controlled, multicenter trial, DESTINY
compared the XIENCE V drug eluting stent to Abbott's bare metal stent, the
MULTI-LINK VISION(R), in patients with CLI of the lower leg. Patients with
lesion lengths less than 40 mm were included in this trial.
The 12-month results from DESTINY demonstrated that XIENCE V had
significantly better patency (absence of vessel blockage) compared to the
MULTI-LINK VISION bare metal stent at 12 months (85.2 percent XIENCE V versus
54.4 percent MULTI-LINK VISION; p=0.0001). This difference was especially
pronounced between six and 12 months, where the difference in patency rate
significantly diverged, as the rate for the bare metal stent fell to nearly
50 percent while the rate for XIENCE V remained above 85 percent. These
results demonstrated that there is a significant benefit from an everolimus
eluting stent versus a bare metal stent. The data from DESTINY were presented
this week at the Leipzig Interventional Course (LINC) 2011, a medical
congress held in Germany for physicians treating endovascular diseases.
"The DESTINY trial demonstrates that everolimus eluting stents result in
significantly better patency at 12 months compared to bare metal stents for
patients with critical limb ischemia of the lower leg, and the use of
everolimus eluting stents can potentially provide significantly better
outcomes for these patients," said Marc Bosiers, M.D., Head of the Department
of Vascular Surgery at St. Blasius Hospital in Dendermonde, Belgium, and
principal investigator of the DESTINY trial. "A drug eluting stent such as
XIENCE PRIME provides European physicians with another treatment option for
patients with short lesions in the lower leg."
In addition to the new indication in Europe for XIENCE PRIME, Abbott has
recently launched a number of key products that provide a range of options
for the treatment of endovascular diseases. The Hi-Torque(R) Winn family of
guide wires is indicated to facilitate the placement of balloon dilatation
catheters during percutaneous transluminal coronary angioplasty (PTCA) and
percutaneous transluminal angioplasty (PTA). PTCA refers to angioplasty
performed in the coronary arteries, while PTA refers to angioplasty performed
in other arteries. These guide wires are available in the U.S. and Europe. In
addition, the Armada 14 PTA catheter, which is available in Europe, has
received 510(k) clearance in the U.S., and is indicated to dilate the
arteries in the legs and kidneys.
About XIENCE PRIME and XIENCE V
XIENCE PRIME is commercially available in CE Mark countries. XIENCE PRIME
offers a novel stent design and a delivery system designed for greater
flexibility and enhanced deliverability. XIENCE PRIME is available in a broad
size matrix, including XIENCE PRIME SV for small vessels and XIENCE PRIME LL
for long lesions.
XIENCE PRIME currently is an investigational device in the U.S. and not
available for sale. The expanded indication for the treatment of CLI or
severe claudication (pain) of the lower leg applies to XIENCE PRIME
exclusively in countries where the product bears a CE Mark.
Abbott's market-leading XIENCE V drug eluting stent is marketed in the
U.S., Europe, Japan and other international markets.
Everolimus, developed by Novartis Pharma AG, is a proliferation signal
inhibitor, or mTOR inhibitor, licensed to Abbott by Novartis for use on its
drug eluting stents. Everolimus has been shown to inhibit in-stent neointimal
growth in the coronary vessels following stent implantation, due to its
Additional information about XIENCE PRIME, including important safety
information, is available online at www.abbottvascular.com.
About Abbott Vascular
Abbott Vascular is a global leader in cardiac and vascular care with
market-leading products and an industry-leading pipeline. Abbott Vascular
offers a comprehensive cardiac and vascular devices portfolio, including
products for coronary artery disease, vessel closure, endovascular disease,
and structural heart disease.
Abbott (NYSE: ABT) is a global, broad-based health care company devoted
to the discovery, development, manufacture and marketing of pharmaceuticals
and medical products, including nutritionals, devices and diagnostics. The
company employs nearly 90,000 people and markets its products in more than
Abbott's news releases and other information are available on the
company's Web site at www.abbott.com.
media, Jonathon Hamilton, +1-408-624-0314,. or Kathleen Rinehart, +1-408-845-1663, or financial, Larry Peepo, +1-847-935-6722, or Tina Ventura, +1-847-935-9390, all of Abbott
Tags: Abbott, Brussels, Europe, January 20