JIM Today 2018 - Thursday - page 7

Issue 1 
 22 February 2018 
JIM today
Surgical aortic valve replace-
ment (SAVR) procedures have seen
traditional success in treating such
diseases, but the effectiveness of
SAVR operations is limited due to
complications and significant mortal-
ity risks, especially for older and
higher risk patients.
The VenusA-Valve is particularly
suited to the Chinese population. “It
is designed with the characteristics
of Chinese patients in mind,” said
Yongjian Wu, Vice director of Cardiol-
ogy, Fuwai Hospital and Cardiovas-
cular Institute, Peking Union Medical
College and Chinese Academy of
Medicinal Sciences, who will speak
during the TAVI symposium. Fuwai
Hospital was where the first implanta-
tion of VenusA-Valve was carried out
in 2012.
Originally, the VenusA-Valve clini-
cal trial was carried out in patients
with tricuspid valves only, with
bicuspid valve patients being enrolled
later. The proportion of patients in
the VenusA-Valve TAVI trial requiring
bicuspid valve treatment was close to
50% (n=118, median age 74 years).
“Bicuspid valves are much more
frequent in Chinese TAVR patients
than in patients
in Europe or the
United States,” Dr
Wu explained to
JIM Today
. “The
VenusA-Valve has
more radial force
which is better suit-
ed to bicuspid and
calcified valves.”
Dr Wu relayed
that the device is
suitable for patients
70 years or over, those with degen-
erative aortic valve stenosis (includ-
ing an autologous aortic valve, and
an artificial aortic valve flap whose
function has been severely damaged),
those with aortic valve stenosis symp-
toms (NYHA class II or above, aortic
valve opening area
0.8 cm
, the
average cross-active valve pressure
difference >40 mmHg or cross-aortic
valve blood flow speed >4.0 m/s). It
is unsuitable for surgical treatment
where the possibility of death, serious
or irreversible pathogenicity is more
than 50%, and where surgical risk
calculation using STS
Finally, Dr Wu added that there
should be no serious distortion, so
the delivery sheath can be expected
to pass through. The diameter of
aortic annulus should be 17-29 mm,
and the distance of lower edge of the
coronary artery opening to the valve
ring should be greater than 10 mm.
“The device means patients can
now be treated through a minimally
invasive procedure as opposed to
traditional open-heart surgery while
on cardiopulmonary bypass,” said Dr
Wu. “Given TAVR’s minimally invasive
nature, patients also make faster pro-
gress in post-operative recovery.”
VenusA-Valve makes history
in China
The VenusA-Valve system is com-
prised of a self-expanding frame, a
porcine pericardial valve, and three
supra-annular leaflets sewn to the
nickel-titanium alloy frame with pol-
ytetrafluoroethylene (PTFE) sutures. It
comes in diameters of 23, 26, 29 and
32 mm. The delivery system includes
a delivery catheter system (DCS) and
a compression loading system (CLS).
The VenusA-Valve registration
study included 101 operative cases
across leading institutions in China,
including Fuwai Hospital, West
China Hospital, The Second Affiliated
Hospital Zhejiang University School of
Medicine, Jiangsu Province Hospital
and Rui Jin Hospital. In the study,
the implantation success rate was
95% and 30-day all-cause mortality
was 5%. In the full analysis set, the
incidence of composite events (all-
cause mortality or severe stroke) at 12
months was 7.1%, which is on par
with international trial results.
Gao Ruilin from Fuwai Hospital,
who lead the research, commented
on how the VenusA-Valve would ben-
efit patients. “The VenusA-Valve is
better suited for the Chinese popula-
tion and physiological characteristics,
with a higher implant success rate,
similar complication rates and lower
two-year mortality rate compared to
earlier generation TAVR products,”
he said.
“The approval of the VenusA-
Valve by the CFDA is a true blessing
for Chinese patients, and a break-
through in the cardiovascular medical
device sector given this product has
been approved in China earlier than
any comparable imported devices.
This makes history.”
Together with Professor Ruilin,
Dr Wu has conducted over 150
procedures with VenusA-Valve. Dr
Wu shared his thoughts based on his
own personal experience with the
device. “Compared to other valves
in China, the VenusA-Valve is the
only product that can deal with
all kinds of lesions. No matter
what the lesion is, simple
or complicated, tricuspid
or bicuspid, VenusA-Valve
is very easy to use, with a
simple release method,
and stable deployment,”
he remarked, adding
that, “Even at the very
early stage, there were no
significant adverse events
recorded with the device.”
Future developments in
aortic valve technology
Venus Medtech also has a trial ongo-
ing for the VenusA-Plus retrievable
valve system. This retrievable system
allows the user to withdraw and
reposition the valve after release,
avoiding adverse events that could
stem from poor valve positioning
and mismatch. The system also
reduces the complexity of the
procedure, which in turn helps to
promote the adoption and applica-
tion of TAVR technology.
In addition, the company has
collaborated with Colibri Heart in the
development of the next-generation,
“disruptive” Venibri Valve – the
world’s first self-expanding pre-
loaded, pre-packaged, ready-for-use,
TAVR system incorporating propri-
etary “dry tissue” technology. It was
recently cleared by the FDA in the US
for use as a soft tissue repair product
by Colorado Therapeutics LLC.
“Compared to other valves
in China, the VenusA-
Valve is the only product
that can deal with all
kinds of lesions.”
Yongjian Wu
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