Scimed
This article was originally published in The Gray Sheet
Executive Summary
Receives approval to market the Maverick, the firm's "first peripheral [percutaneous transluminal angioplasty] catheter designed for large blood vessels," Dale Spencer, Scimed president and CEO, reported at the June 15-17 Piper Jaffray conference in Minneapolis. The firm received 510(k) clearance to market the device on May 20. Scimed says that the catheter is suitable for larger vessels located above the knee, as opposed to the firm's Viper, which is indicated for lower-leg vessels. The firm is waiting to accumulate a more broad product line for peripheral vessels before it adopts a "targeted" marketing approach for the Maverick, which sells for between $100 and $200. Scimed also plans to begin clinical trials later this year for a non-PTCA intravascular therapeutic catheter, Spencer said.