April 2019 digital edition

emains undetected.
Participants had both an
iPhone and an Apple Watch.
A special app checked each
participant’s heart-rate pulse
sensor for an irregular pulse,
intermittently. The participant
would receive a notification
and was asked to schedule
a telemedicine consultation
with a study doctor. Then the
participant would be sent
ambulatory ECG patches to
record the rhythm of their heart
for up to a week.
Overall, only 0.5 percent
of participants received
irregular pulse notifications,
an important finding given
concerns about potential
over-notification. Comparisons
between irregular pulsedetection
on Apple
Watch and simultaneous
electrocardiography patch
recordings showed the pulse
detection algorithm has a 71
percent positive predictive
value.
Eighty-four percent of the
time, participants who received
irregular pulse notifications
were found to be in atrial
fibrillation at the time of the
notification. 34 percent of
the participants who received
irregular pulse notifications and
followed up by using an ECG
patch over a week later were
found to have atrial fibrillation.
Since atrial fibrillation is an
intermittent condition, it’s
not surprising for it to go
undetected in subsequent ECG
patch monitoring.
Fifty-seven percent of those
who received irregular pulse
notifications sought medical
attention.
BD’s venous
stent gets US
FDA approval
The US FDA has granted
premarket approval for
the Venovo venous stent, the
first stent indicated to treat
iliofemoral venous occlusive
disease, BD announced.
The Venovo venous
stent is a flexible nitinol stent
specifically designed to reopen
blocked iliac and femoral veins
in order to maintain adequate
blood flow. The Venovo
venous stent is designed with
a balance of radial strength,
compression resistance and
flexibility needed for the
treatment of symptomatic
post-thrombotic and
non-thrombotic iliofemoral
lesions.
The broad stent sizing
allows clinicians to treat large
diameter veins and long lesion
lengths.
One-year results from
the prospective, multicentre
single-arm VERNACULAR
trial involving 170 subjects
demonstrated the safety
and effectiveness of the
Venovo venous stent for the
treatment of symptomatic
iliofemoral venous outflow
obstruction.
The clinical findings
showed a weighted primary
patency rate of 88.3 percent,
with a 96.9 percent patency
rate in non-thrombotic lesions
and an 81.3 percent patency
rate in post-thrombotic lesions
at 12 months, exceeding
the performance goal of 74
percent.
In addition, patients treated
with the Venovo venous
stent reported a statistically
significant reduction in pain
symptoms, according to the BD
statement.
Ortho’s dual slide
testing platform
under USFDA
review
O
rtho Clinical Diagnostics
has received CE Mark for
Ortho’s Vitros XT MicroSlide, a
new multi-test technology that
allows labs to run two tests
simultaneously.
Ortho’s Vitros XT MicroSlide
is powered by Digital Chemistry,
Biotronik’s tachycardia devices get US FDA clearance
Acticor and Rivacor highvoltage
cardiac rhythm
management (CRM) devices
for treatment of patients with
cardiac arrhythmias secured
approval from US FDA,
Biotronik said.
The six new tachycardia
solutions include Rivacor VR-
T, Rivacor DR-T, Rivacor HF-T
QP, Acticor DX, Acticor CRT-DX
Bipolar and Acticor CRT-DX.
The Acticor and Rivacor
systems are designed to
incorporate more diagnostic
and therapeutic capabilities in
smaller devices with extended
battery longevity.
This provides physicians
with more comprehensive
therapy options when
treating cardiac patients with
varying disease states and
comorbidities. With a smooth,
elliptical BIOshape, Acticor and
Rivacor devices are the smallest
and slimmest 3 Tesla (3T) MRconditional
CRM devices on the
market.
The slim devices have
rounded edges that lessen skin
pressure and help to lower
the risk of skin erosion while
increasing patient comfort.
Extended longevity—nearly
15 years for VR-T, 13.5 years
for DR-T, 14 years for DX and
nine years for CRT—can lead
to fewer device replacements,
fewer procedures for patients
reducing risks, complications
and costs.
The Acticor devices offer
DX technology, which provides
atrial diagnostics without an
atrial lead. DX systems can
detect silent atrial fibrillation
for stroke prevention, enhance
diagnostic accuracy for better
clinical decision-making
and allow for dual-chamber
supraventricular tachycardia
(SVT) discrimination to
prevent unnecessary shocks.
By reducing the number of
leads in the device system, DX
technology also enables faster
procedure times, lowers cost
and reduces complications.
This intelligent CRT
AutoAdapt programming
automatically adjusts to
changes in patient conditions,
enabling real-time responsive
care while saving time for
physicians and hospitals.
April 2019 / FUTURE MEDICINE / 73