) gained 5.5% following the announcement of expanded clearance by
U.S. Food and Drug Administration (FDA) for its AngioVac cannula
for venous drainage.
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The expanded clearance seems reasonable given the wide acceptance
of the product across the U.S., since its introduction in Oct
2012, on the back of its ability to improve patient outcomes and
lower cost of treatment.
The expansion includes removal of undesirable intravascular
material such as fresh, soft thrombi or emboli during
extracorporeal bypass for up to six hours done to patients
suffering from venous thromboembolic disease (VTE).
The AngioVac cannula and circuit facilitates drainage, filtration
and reinfusion of blood for up to six hours by making an
extracorporeal bypass circuit in combination with other
manufacturers' filters, pumps and return cannula. It has a
proprietary balloon-actuated, expandable, funnel-shaped distal
tip to enhance flow and prevents clogging of the cannula.
About one million people are affected by VTE disease till date
and more than 300,000 deaths have caused by it across the U.S.
There are alternative treatments to this disease such as
Pharmacomechanical therapies, catheter-directed thrombolysis, and
anticoagulant therapy but they can lead to major bleeding
Recently, ANGO also revealed that it has received 510(k)
clearance for its BioFlo DuraMax chronic hemodialysis catheter
from FDA, making it the third approval from the authority for its
BioFlo product lienup in Vascular Access business.
The BioFlo DuraMax is helpful in treating thrombotic occlusions,
which are prevalent in up to 40% of dialysis patients. This
advanced dialysis catheter is equipped with Endexo technology.
The commercial launch of the catheter, which is expected in the
fourth quarter of fiscal year 2014, is likely to boost ANGO's 15%
share in the $100 million chronic dialysis catheter market in the
ANGO currently carries a Zacks Rank #3 (Hold). Some better-ranked
stocks in the medical instruments industry with a favorable Zacks
Natus Medical Inc.
Syneron Medical Ltd.
). All of them carry a Zacks Rank #1 (Strong Buy).