Boston Scientific launches crossing device to treat blockages in
9 February 2012
Boston Scientific Corporation (NYSE: BSX) has launched in the
USA the TruePath CTO Device, designed to facilitate the crossing of
chronic total occlusions (CTOs, or complete blockages) within the
The Company will begin marketing the product immediately in the
US and expects to launch the product in Europe and other
international markets in the first half of 2012.
CTOs, which represent complete artery blockages, are extremely
difficult to treat with standard endovascular devices such as
guidewires and other catheter-based technologies. CTO devices permit
endovascular treatment in cases that otherwise might require a
patient to undergo bypass surgery or risk lower extremity
"CTOs are very challenging, requiring additional time, resources
and patient exposure to imaging contrast and radiation," said J. A.
Mustapha, M.D., Director of Endovascular Intervention at Metro
Health Hospital in Wyoming, MI. "The TruePath device is an exciting
new technology that allows me to effectively penetrate these
difficult blockages with greater speed and ease, allowing access to
untreated lesions and helping to improve overall patient outcomes."
The TruePath CTO Device features a rotating diamond-coated tip
designed to break through occluded peripheral arteries and
facilitate the placement of conventional guidewires for treatment of
peripheral lesions. The ultra-low 0.018" profile is roughly half the
size of competitive devices and is engineered for optimal crossing.
Once positioned, the distal tip rotates at 13,000 rpm to facilitate
drilling through calcified lesions and other fibrous blockages. The
TruePath device requires no capital equipment and is available with
an optional extension wire to facilitate catheter exchange and
increase the working length beyond 300 cm.
"The TruePath device is another example of innovation in our
priority growth area targeting peripheral vascular disease, where a
significant number of patients remain undiagnosed or untreated,"
said Jeff Mirviss, President of the Boston Scientific Peripheral
Interventions Division. "This innovative crossing device further
expands our growing peripheral interventions portfolio and offers
physicians an option to treat patients with challenging lesions in
the lower extremities who may have otherwise faced amputation.
Addressing this growing health problem through the use of
less-invasive devices could greatly improve patient care and
ultimately save limbs."
The ReOpen clinical study evaluated the TruePath CTO Device in 85
patients with peripheral artery lesions. Study results demonstrated
the device is safe and effective in facilitating the crossing of
intraluminal CTOs following resistance or prior failed attempts with
a conventional guidewire. In the study, technical success (defined
as facilitation of CTO crossing) was achieved in 80.0 percent of
patients, while improved post-procedure blood flow was demonstrated
in 82.4 percent of patients. Safety was demonstrated with a 98.8
percent freedom from clinical perforation at the time of procedure.
An estimated 17.6 million Americans and more than 30 million
people worldwide suffer from peripheral vascular disease, which
is characterized by blockages in vessels of the lower limbs and
associated with high rates of morbidity and mortality. CTOs are
estimated to be present in approximately 40 percent of patients
treated for symptomatic peripheral artery disease.
Boston Scientific acquired the TruePath technology through its
acquisition of ReVascular Therapeutics, Inc. in February 2011. The
TruePath CTO Device has received 510(k) clearance from the U.S. Food
and Drug Administration and carries CE Mark approval.
Source: Boston Scientific