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Spectranetics Takes CLiRpath To 510(k) Clearance For Leg Artery Occlusions

This article was originally published in The Gray Sheet

Executive Summary

Spectranetics will support a U.S. clinical trial for expanded use of its CVX-300 excimer laser technology for heart attacks with incremental profits from CLiRpath leg artery occlusion treatment sales

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David Jenkins returns as EP MedSystems CEO: EP MedSystems Chairman and Founder David Jenkins is named president, CEO and COO after the board of directors fires Reinhard Schmidt for "cause." An internal audit found that Schmidt made inaccurate statements to the Department of Commerce and the U.S. Attorney's Office for the District of New Jersey during an investigation into the firm's product sales to Iran, which are forbidden by U.S. law. The government is also investigating the accuracy of statements certified and authorized by Schmidt. No financial irregularities have been discovered. Jenkins, who served as EP MedSystems' CEO from 1993-2002, headed up gastric electrical stimulation device developer Transneuronix before Medtronic acquired it for $260 mil. in July (1"The Gray Sheet" July 4, 2005, p. 10)...

People In Brief

David Jenkins returns as EP MedSystems CEO: EP MedSystems Chairman and Founder David Jenkins is named president, CEO and COO after the board of directors fires Reinhard Schmidt for "cause." An internal audit found that Schmidt made inaccurate statements to the Department of Commerce and the U.S. Attorney's Office for the District of New Jersey during an investigation into the firm's product sales to Iran, which are forbidden by U.S. law. The government is also investigating the accuracy of statements certified and authorized by Schmidt. No financial irregularities have been discovered. Jenkins, who served as EP MedSystems' CEO from 1993-2002, headed up gastric electrical stimulation device developer Transneuronix before Medtronic acquired it for $260 mil. in July (1"The Gray Sheet" July 4, 2005, p. 10)...

Med Tech Earnings Calls In Brief

Guidant restructures to cover stents: Guidant will take a Q3 charge of $50 mil.-$70 mil. to cover severance and benefits packages for employees terminated to offset declining coronary stent sales. Lay-offs will be company-wide, but will especially hit the firm's vascular intervention unit and manufacturing plants in Temecula and Santa Clara, Calif. Stent revenue fell 46% to $120 mil. in Q2 compared with the same quarter of 2003. The product category is expected to account for 13% of Guidant's business in 2004 and 10% in 2005 - down from 23% last year. Increasing popularity of drug-eluting stents dragged down revenue, as did competitive pressures in Japan, where the firm experienced a 60% decline in stent sales. Improved sales of ICDs likely will compensate for the declines. Guidant expects the defibrillators to compose 47% of total sales in 2004 and 51% in 2005 - up from 41% in 2003. Excluding a charge of $49 mil. for in-process R&D, the firm earned $185 mil. on sales of $938.8 mil. Guidant expects Q3 revenue to be $890 mil.-$930 mil. For the year, the firm forecasts revenue of $3.65 bil.-$3.75 bil. For fiscal 2005, sales are projected to be $3.9 bil.-$4.1 bil...

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