|[February 14, 2013]
ReCor Medical begins ACHIEVE post-market study with its Generation-2, ultrasound-based PARADISE™ renal denervation system
MENLO PARK, Calif. --(Business Wire)--
Medical announced today that it has commenced a 50-patient,
post-market study across multiple sites in Europe with its CE-marked next-generation
PARADISE system, a minimally invasive 6Fr Over-The-Wire
(OTW) ultrasound device for treating resistant high blood
pressure. The first patients in the study have been enrolled at the
Thoraxcenter, Rotterdam, the Netherlands. Both patients were treated
quickly with no device or procedural complications.
The treatment parameters of the Gen-2 PARADISE System have been enhanced
to optimize nerve damage through a 30-second energy delivery while
maximizing endothelial protection with its unique cooling mechanism.
PARADISE is the only CE-marked system for renal denervation that is
based on ultrasound, not radiofrequency (RF), energy.
"The enhanced features of our Gen-2 PARADISE System, including an
over-the-ire 6Fr device and a faster procedure, are designed to offer
patients a superior, noninvasive treatment option to reduce their blood
pressure," said Mano Iyer, CEO of ReCor Medical.
The benefit of ReCor's PARADISE ultrasound approach is three-fold: (1)
to penetrate deep into the tissue where the majority of nerves are
located; (2) to deliver heat circumferentially, to target all of the
renal nerves in one location; (3) to simultaneously cool the artery
wall's surface to protect the vessel.
"Our novel ultrasound approach is designed to be more effective than
radiofrequency (RF), which is restricted in its depth of penetration to
just a few millimeters because of inconsistent arterial wall contact, in
addition to RF's inability to heat circumferentially in any given
location," added Iyer. "Equally important, RF technologies
generate unnecessary heating at the level of the arterial wall.
Indeed, data presented at TCT 2012 concluded that renal nerves are
actually much further at depth than previously thought, and run circumferentially
around the renal arteries, which dramatizes the PARADISE ultrasound
About ReCor Medical, Inc.
ReCor is a private venture-backed, early-stage company developing novel
therapeutic ultrasound catheter technology. ReCor is backed by
European and U.S. investors, including Sofinnova Partners, one of
the largest life science investors in Europe. The Company's PARADISE™ ultrasound
catheter, which is CE-marked, is designed with the aim to allow
complete circumferential denervation
more consistently and efficiently than the standard of care radiofrequency
ablation catheter. For more information about ReCor Medical, please
NOTE: PARADISE™ is approved for sale in Europe; it is not
approved for sale or investigational use in the United States.
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