FDA Expands Angiovac Clearance for AngioDynamics - Analyst Blog

Shares of AngioDynamics Inc. ANGO gained 5.5% following the announcement of expanded clearance by U.S. Food and Drug Administration (FDA) for its AngioVac cannula for venous drainage.

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 complications.

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 U.S.

ANGO currently carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the medical instruments industry with a favorable Zacks Ranks include Cynosure Inc. CYNO, Natus Medical Inc. BABY, and Syneron Medical Ltd. ELOS. All of them carry a Zacks Rank #1 (Strong Buy).