EV3 announced yesterday their quarterly numbers including sales of their Fox Hollow (Silverhawk) Atherectomy device. Sales of the Silverhawk were down sequentially from the prior quarter and were barely mentioned on the Management Call with the Street. Interesting to see this given the prior quarterly Silverhawk sales were up sequentially from the prior quarter and EV3 Management had called it a "major turning point" in their on-going battle with CSI and Pathway Medical.

"Whisper word" on the Street is that CSI may again show little growth, if any, off their flat sequential quarterly sales reported for the Diamondback last quarter. Two quarters in a row of flat sales, for what is a "growth story stock" would not likely to be very well received by investors.

At the VIVA Conference in Las Vegas last week (biggest Peripheral Conference in the world), there was little talk of any momentum in the overall Atherectomy market. Looking like sales of all the competitors (CSI, Pathway, and Fox Hollow)remian fairly flat indicating Atherectomy, as an alternative to Plain Old Balloon Angioplasty (POBA), is gaining little traction in the market. In fact, the total sales today of all three companies just about equal what Fox Hollow was doing alone two years ago before their disasterous sale to EV3.

For those hoping that somehow getting a Coronary indication for the Dimondback is the "key to success", you will have a long wait for any approval in the U.S. (several years at least) since to date, CSI has not even announced they have received an approved IDE from the FDA to begin a PMA trial for that indication.

Finally, sales in Europe or Asia for Atherectomy, in general, have been very weak due to the huge cost differential compared to POBA and no published clinical data suggesting that Atherectomy is worth that cost differential. The one small study done in India, which showed positive results, is not likley to change that overall impression anytime soon. It will take a lot more good clinical data, from other reputable sources,all of which takes time and money with no absolute assurnace of success.

These are very challening times for all medical device companies, but products that are very expensive (compared to alternatives) and provide no well documented clinical evidence (published data in peer reveiwed major journals), face the most challening road of all.