since 2010. Telemetry devices of this kind are quickly surpassing the traditional
Holter devices, due to their broader coverage and increased accuracy.
However, since it is a fairly new medical device technology, remote monitoring struggles to gain a wide foothold. “Despite strong technology advances in this
area, development of the market continues to be hindered by changes to reimbursement,” says Nicola Goatman, IHS Analyst. “As reimbursement continues to
decline, remote cardiac monitoring service providers struggle to stay afloat in an
increasingly unpredictable market.”
Bioresorbable Vascular Scaffolding
Stents are one of the most traditional, well-established cardiovascular devices,
but recent concerns over restenosis and late stent thrombosis (LST) have created
a renewed need for further development. When drug-coated stents came along,
there was a temporary solution to the problem; however, the polymer material
that typically bonds the drug to the stent often causes the very LST it had originally sought to prevent. Following the trends of the more recent biocompatible
materials, “disappearing stents,” or bioresorbable vascular scaffolds (BVS), were
created. These types of devices are designed to dissolve in the body over time.
The ABSORB BVS is one such absorbable device by Abbott Vascular, which was
recently introduced to the European market. Plans to introduce the product in
the U.S. are currently set for 2016.
Other products are currently testing biodegradable polymers in the race for
FDA approval, including the EVOLVE II Synergy stent by Boston Scientific
and the COMPARE II BioMatrix by Biosensors. CorMatrix Cardiovascular has
been the most recent recipient of three U.S. patents for replacement heart valves
that utilize a completely unique biomaterial called extracellular matrix (ECM).
“Extracellular matrix is a naturally occurring substance that helps regulate cells
and is present in all humans and animals,” said Robert Matheny, M.D., chief
scientific officer for CorMatrix. “After sterilization and testing, CorMatrix ECM is
an exceptionally strong, but very pliable and thin sheet that can be sewn onto the
heart to facilitate the repair of different heart structures,” said Dr. Matheny.
Endovascular & Transcatheter: Replacement and Repair
Other areas seeing significant headway are devices that enable endovascular
aneurysm repair. “The next frontier involves the treatment of aneurysms that are
close to the renal arteries,” says Louise Murphy, of Millenium Research Group
(MRG). “A new generation of grafts, termed fenestrated or branched grafts have
cut-outs for the renals, with renal graft insertions, giving the stent graft arms.”
These grafts are highly versatile, such as the Zenith Fenestrated, by Cook Medi-
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New remote monitoring technology may see ECG sensors attached to smartphones
rather than more traditional looking medical devices.