Hotspur's GPSCath allows multiple vascular procedures from single
31 Jan 2011
Hotspur Technologies, Inc. has announced the first
commercial deployment of its GPSCath Balloon Dilatation Catheter. This
new device enables, for the first time, multiple vascular procedures to
be performed with one catheter, potentially reducing procedure time and
expense for both patients and medical professionals.
The GPSCath is a two-in-one device that allows physicians to
perform high-pressure angioplasty and inject physician-specified
fluids such as contrast while maintaining guidewire position.
The procedure was performed by Dr Bruce Lin MD and Dr. Stephen
Liu MD, Interventional Radiologists at Lifelink Interventional
Center in Modesto, California.
"The Hotspur GPSCath balloon is a superior alternative to a
non-compliant ultra-high-pressure legacy devices currently in use,"
said Dr Lin. "This is because the flexible nature of the Hotspur
device allows tactile and visual feedback on the stenotic lesion,
while still providing the performance of a ultra-high-pressure
"In addition, the value added feature enables operators to
conveniently maintain guidewire position while delivering
therapeutic drugs and evaluating results of interventions. This is
especially attractive when treating difficult or occlusive lesions.
Hotspur is setting a higher bar for peripheral and dialysis access
During the first procedure, Dr Liu successfully restored blood
flow through the patient's dialysis access graft by inflating a 7mm
GPSCath balloon to 20ATM to open a blockage within the graft. After
performing the angioplasty, without removing the balloon, Dr Liu
then opened the proprietary valve on the distal end of the GPSCath
balloon catheter and successfully injected contrast to visualize the
Dr Liu followed with a second procedure performing both functions
utilizing a 6mm GPSCath balloon. In the past for these types of
treatments, physicians typically had to perform multiple catheter
exchanges to open the vessels and visualize results, which can be
time-consuming and expensive due to the use of multiple catheters.
Hotspur's products aim to use one catheter for the entire procedure.
"We are committed to enabling medical professionals to perform
peripheral access procedures with devices that both simplify and
improve the doctors' and patients' experiences," said Gwen Watanabe,
president and CEO of Hotspur. "Our key goal is to bring innovation
to markets that have had less focus because they are so fragmented."
Watanabe indicated that, based on recently released data, there
are almost 20 million patients with peripheral vascular disease that
could benefit from this multi-purpose approach to catheter design
for the peripheral access market.
The GPSCath is the one of three Hotspur devices that have
received 510(k) clearance from the US Food and Drug Administration.
These devices are focused on solving some of the key challenges
associated with restoring blood flow to blocked or low flow dialysis
access grafts and fistulaes and peripheral vessels.
In addition to the GPSCath, the IQCath Balloon Dilatation
Catheter is a specialty three-in-one device that allows the
physician to perform angioplasty, embolectomy, and fluid injection
with the same catheter while maintaining guidewire position; and the
Keeper Embolectomy Catheter is a specialty two-in-one device that
integrates an embolectomy balloon with the ability to inject
physician-specified fluids while maintaining guidewire position.
These products are commercially available in the United States.
The foundation of Hotspur's commercial devices is a groundbreaking
technology known as the VisioValve injection system. This innovation
utilizes a proprietary valve system that allows a physician to
perform angioplasty or clot removal and perform an injection of
physician-specified fluids without having to remove the guidewire or