FDA Clears Angio's BioFlo PICC

Therapeutic and diagnostic devices maker, AngioDynamics Inc. ( ANGO - Analyst Report ) recently received 510(k) approval from the U.S. Food and Drug Administration (FDA) for its BioFlo peripherally inserted central catheters (PICCs) with Endexo technology. In comparison to other commonly used PICCs, the BioFlo technology lowers the accumulation of catheter-related thrombus, both outside and inside the catheter by 87% on an average, based on platelet count.

AngioDynamics plans to launch BioFlo PICCs in the second quarter of fiscal 2013. These latest devices from the vascular access division are the first of its kind to offer BioFlo technology in the U.S.

In addition, the permanent and non-eluting polymer, the Endexo technology, renders long-term durability to BioFlo PICC and the PASV Valve Technology design resists backflow, lowering blood reflux that could lead to catheter-related complexities.

AngioDynamics is a market leader in several of its operating segments including angiographic products and thrombolytic catheters. It caters to 15% of the $375 million U.S. PICC market, thereby holding the second spot in the region. The Access business grew 8.5% to $18 million in the last reported quarter. The availability of the advanced BioFlo PICC catheter with the PASV Valve Technology will further boost the company’s vascular access products portfolio.

The BioFlo PICC products have already received CE Mark and Canadian approval along with other international approvals. Furthermore, AngioDynamics plans to apply for FDA approval for its BioFlo ports and BioFlo dialysis catheters product lines following the successful Canadian launch of the BioFlo technology with PASV PICCs.

Meanwhile, NanoKnife remains the life blood for AngioDynamics and the company intends to expand the label to capitalize on its commercial opportunities. The company is further ramping up research and development (R&D) investment to expand its product portfolio and support the ongoing clinical studies of NanoKnife and vascular product development programs.

However, AngioDynamics’ product lines face strong challenges from the competitive offerings of larger rivals such as Boston Scientific ( BSX - Analyst Report ) and C.R. Bard ( BCR - Analyst Report ) . We currently have a Neutral recommendation on AngioDynamics, which carries a short-term Zacks #3 Rank (Hold).