MEDICAL DEVICE INNOVATION - Medical Device Daily

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New stent for tough-to-treat
coronary artery bifurcations
By LYNN YOFFEE
Medical Device Daily Staff Writer
Interventional cardiologists have long been challenged
by coronary artery bifurcation lesions – branches or forks
in the arteries – because treating those areas is associated
with an increased risk of heart attack, restenosis and death.
Three-year-old Stentys (Princeton, New Jersey and Paris)
has just received a CE mark for what it says is the very first
stent system that’s disconnectable and-self-expanding, a
platform specifically designed to treat coronary artery
bifurcations.
“Regular stents are made of steel that are like little
metallic tubes that don’t move,” Stentys CEO Gonzague
Issenmann told Medical Device Daily. “Our stent acts as a
spring. This is the novel part. Other stents are not selfextending.
They stay where they are. The Stentys platform
combines those two novel features (disconnectable and
self-expanding). That’s unrivaled in this space and caters to
the specific needs for difficult and challenging situations
for the cardiologist.”
The disconnectable feature allows cardiologists full
access to a side branch of the artery and placement of a
second stent. “You can’t fit a tube into a Y branch,”
Issenmann said. “The procedure used today to treat with
regular stents is well known and accepted. It’s a provisional
stenting technique for bifurcations where you put a regular
stent in main branch and try to find your way into the
side branch. It doesn’t scaffold well and you need to do a lot
of ballooning. These techniques force the cardiologist to
treat the side branch first and that’s counterintuitive
because they want to treat the most important vessel first.
“We propose something that has the advantage of
keeping that same technique, but it’s made easier by the
disconnection feature that allows the cardiologist to open
up the stent without distorting it. The advantage is that you
use the same routine except that when you embark in the
procedure, you can decide whether you want to access the
side branch or not,” he said.
The Stentys stent actually looks like it has a side door.
The self-expanding feature ensures optimal apposition in
the critical initial hours and days after an acute myocardial
infarction (AMI) procedure, according to the company. It’s
constantly applied to the vessel surface during thrombus
and vessel spasm relief, therefore avoiding malapposition,
a significant concern to cardiologists. Although the CE
mark was issued in connection with the bifurcation indication,
Issenmann said it’s also specifically designed for AMI
procedures.
“It’s built with special titanium alloy that gives the stent
properties to act as a spring and can expand and push on
vessel walls,” he said. “Patients who suffer from AMI are
MEDICAL DEVICE INNOVATION 2010
brought to the cath lab and basically they are there to
reopen and recreate the flow with a stent,” he said. “The
problem is they are using stents designed to treat blockages
of the coronaries that occur over time. They are not
the ones that occur acutely.
When you have this clotting of the artery that occurs
immediately, you have a chain reaction in the artery; clots
and spasms make it smaller. With a regular stent, you have
a problem with sizing. The stent is often not properly
apposed to the vessel wall. This is one of the biggest predictors
of reclotting later on – because it wasn’t properly
placed where the initial clot was.”
Issenmann said the Stentys stent “allows for perfect
apposition of the stent to prevent malapposition and
recurrence of clots. Only a self-expanding stent can do
that.” He added that the stent ultimately reduces the potential
for restenosis.
To obtain the CE mark, Stentys used data from its OPEN
I (First-In-Man study of the Stentys Coronary Bifurcation
Stent fOr the Percutaneous treatmEnt of de-novo lesions in
Native bifurcated coronary arteries) study. Forty patients
were enrolled in OPEN I between September 2007 and
September 2008 at nine European clinical sites.
The prospective, non-randomized, single-arm, multicenter
safety and feasibility study found that it was safe,
doesn’t fracture over time, has results similar to balloonexpandable
bare metal stents, provides excellent crossover
treatment of bifurcations, the stent remained perfectly
opposed to the treated vessels and there were no deaths
or reoccurrence of heart attack during the six-month follow-up
period. The company intends to start commercializing
the stent in Europe during the first half of 2010 and has
started discussions with FDA, although no U.S.-based studies
are yet planned.
Stentys is currently conducting another trial with the
same stent seeking CE mark for the AMI indication. Another
larger study will begin later this year that will compare the
Stentys stent with a balloon expandable stent. Stentys last
month managed to secure the second tranche of a Series B
financing, closing an additional $4.2 million investment
from new investor bringing the total B round financing to
more than $22 million (MDD, June 30, 2009).
“Basically the proceeds of this are good toward the continuation
of our clinical program,” Issenmann said. “We
actually raised more than expected, so that gives us even
more runway. In all fairness, we were fortunate. When I hear
war stories about what’s going on in the U.S. to raise
money, I know we have an advantage of being on both
sides of the ocean.”
Stentys was co-founded by Issenmann and Jacques
Séguin, MD, founder of CoreValve, a company acquired earlier
this year by Medtronic (Minneapolis) for $700 million.
(This story originally appeared in the July 8, 2009, edition
of Medical Device Daily).
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