AngioDynamics Inc. (ANGO - Free Report) announced the receipt of 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Celerity tip location system. The system will be used as a supplement to assist in the placement of Peripherally Inserted Central Catheters (PICC) in adult patients.
The Celerity tip location system uses Electrocardiography or ECG instead of chest X-ray and fluoroscopy to confirm the location of a PICC. Following the approval, ANGO expects to initiate the U.S. distribution of the system at the beginning of July this year.
In Mar 2014, the FDA rejected the initial 510(k) application for the Celerity tip location system forwarded by Medcomp Inc., ANGO’s global distribution partner. Subsequently, ANGO executed an agreement with Medcomp and Medcomp’s development partner to gain regulatory control over the Celerity platform and resolved to bring the system to the U.S. market by mid-summer.
In Sep 2013, Medcomp received Health Canada’s approval for the commercial sale and distribution of its Celerity tip location system in Canada. Circulation of the system in Canada was initiated in Oct 2013. The Canadian market continues to see a positive market response to the combined offering of the Celerity system with ANGO’s thrombus-resistant BioFlo PICC.
The Celerity system when combined with ANGO’s BioFlo technology provides unique clinical and economic advantages to the company. Recently, ANGO also revealed that it has received 510(k) clearance for its BioFlo DuraMax chronic hemodialysis catheter from the FDA, marking the third U.S. clearance for its BioFlo product line-up in the Vascular Access business.
The commercial launch of the catheter, which is expected in the fourth quarter of fiscal 2014, is likely to boost ANGO’s current 15% share in the $100 million U.S. chronic dialysis catheter market. With the growing interest in thrombus-resistance PICCs, ANGO’s innovative BioFlo is becoming increasingly popular among nephrologists and dialysis centers.
The novel BioFlo platform has successfully made a turnaround in the company’s Vascular Access business, which has been facing considerable weakness for the last two years. The segment reflected the first signs of growth in the last reported quarter. The combined offering of the Celerity tip location system and the BioFlo technology is poised to strengthen ANGO’s Vascular Access business over the long term.
ANGO currently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical instruments industry include Alphatec Holdings, Inc. , RTI Surgical Inc. (RTIX - Free Report) and Luminex Corporation (LMNX - Free Report) . All these stocks sport a Zacks Rank #1 (Strong Buy).