FM JANUARY 2019 - digital edition

Device programme was
established under the 21st
Century Cures Act to facilitate
more rapid patient access to
breakthrough technologies
with the potential to
address life-threatening
disease conditions for which
no approved or cleared
treatment alternatives exist.
Aethlon has recently
demonstrated the ability of
the Hemopurifier to capture
exosomes underlying several
forms of cancer, including
breast, ovarian and metastatic
melanoma.
The Hemopurifier is a
single-use device indicated for
the treatment of individuals
with advanced or metastatic
cancer who are either
unresponsive to or intolerant
of the standard of care
therapy and with cancer types
in which exosomes have been
shown to participate in the
development or severity of
the disease, according to the
company.
Philips V60 Plus ventilator
receives CE mark
Philips V60 Plus
ventilator has received
CE mark approval, Royal
Philips announced.
The device integrates
non-invasive ventilation
(NIV) with high flow
therapy (HFT) in a single
device. Clinicians can
rapidly adjust therapies
around constantly
changing patient
conditions without having
to switch devices.
Designed for early
intervention in respiratory
failure, the V60 Plus
enables clinicians to
further enhance patient
outcomes with less invasive
respiratory care therapies,
while improving clinician
workflow and maximizing
equipment investments.
The complementary
modes in one device can
simplify both workflow and
device availability.
The V60 Plus has
received CE mark and is
available for sale in Europe,
and the US FDA 510k has
been submitted, according
to Philips.
India’s drug
regulator clears
Meril’s Myval
The Central Drugs Standard
Control Organization
(CDSCO), India’s top drug
regulator, has granted
approval for Myval-
Transcatheter Aortic Heart
Valve Replacement (TAVR)
technology from Meril Life
Sciences.
The device is the first
indigenously developed
and manufactured TAVR
technology.
Headquartered in Vapi,
Gujarat, the company received
approval for the Myval TAVR
technology on the basis of
successful results from clinical
study done in India.
With the launch, Meril Life
will become the first Indian
company to commercially
make this therapy available
in the country. The company
will soon bring the next
generation treatment modality
to thousands of patients
across the country and
globally, Meril said in a press
release.
Spiration valve to
treat emphysema
gets US nod
The US FDA approved
Spiration Valve System
(SVS) for the treatment
of severe emphysema, a
progressive form of Chronic
Obstructive Pulmonary
Disease (COPD), Olympus said.
Placed in targeted airways
of the lung during a short
bronchoscopic procedure, the
Spiration Valve is an umbrellashaped
device that improves
breathing by blocking airflow
to the diseased portion of
the lung. SVS therapy leads
to volume reduction in the
treated part of the lung,
allowing the healthier tissue in
the remaining portion of the
lung to function better.
FDA approval of the
SVS is based on results
of the EMPROVE clinical
trial demonstrating that
patients treated with the SVS
benefited from statistically
80 / FUTURE MEDICINE / JANUARY 2019