) announced the receipt of the U.S. Food and Drug Administration
(FDA) 510(k) clearance for the LigaSure Maryland jaw
open/laparoscopic sealer/divider. The FDA approval comes as a
respite for Covidien given that it has very recently decided to
withdraw its OneShot Renal Denervation program owing to low
demand in the market.
The approval will give Covidien access to a vast market,
simultaneously widening prospects for the industry-leading vessel
and tissue sealing portfolio of the company.
In addition to the FDA go-ahead, Covidien has completed all the
major European adherences needed to win the European CE Mark for
the product. The company hopes to launch the new vessel sealer
and divider in the U.S. and the European Union in the current
Along with Covidien, companies like
) continue to compete in the laparoscopic devices market that
could potentially worth $7.5 billion by 2018.
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The product comes in three lengths, among which, the 37 cm
version will be available to select customers in 2014, while the
shorter 23 cm and the longer 44 cm versions will be launched in
the latter part of the year.
The LigaSure Maryland jaw device integrates LigaSure's
energy-based vessel sealing technology with three common surgical
tools to enhance efficiency during laparoscopic and open
surgeries. The three tools are a Maryland dissector - a blunt
surgical tool with a curved jaw used to separate, grasp and
manipulate tissue; an atraumatic tissue grasper and cold surgical
scissors. The novel design of this jaw device is meant to
facilitate surgeons to grasp, seal and cut tissue, in minimal
steps using less instrument exchanges.
Covidien expects minimally invasive procedures in urologic,
vascular, thoracic and thoracoscopic, and gynecology, wherein
ligation and division of the vessels is performed, to benefit
from the usage of this novel jaw device.
Foreseeing the ample opportunity offered by the dynamic medical
devices industry, Covidien has already completed two important
deals in the emerging economies of Brazil and China. We believe
this medical device maker is headed for robust growth on the back
of more such developments in the near term.
Currently, Covidien carries a Zacks Rank #2 (Buy).
Investors interested in the medical devices industry can also
consider other top-ranked stocks like
Cardiovascular Systems Inc
). Both these stocks sport a Zacks Rank #1 (Strong Buy).