
Thursday, January 24, 2013 10:02:11 AM
In imaging, we submitted a 510(k) application to expand indications for our Firefly Fluorescence imaging system to use in biliary imaging. We believe this will have application for use in imaging in the common bile duct during Cholecystectomy, and we’ll complement the use of Single-Site.
The year-over-year increase in I&A was driven by procedure growth of approximately 25%, sales of new instrument and accessory products, including Single-Site, Vessel Sealer and Firefly and higher stocking orders associated with higher system unit sales.
Instrument and accessory revenue realized per procedure including initial stocking orders was approximately $2,050 per procedure, which is higher than the $1,980 realized in the fourth quarter of 2011, and the third quarter of 2012. The sequential year-over-year increases were driven by higher new product sales, including Vessel Sealers, Single-Site kit, and Firefly kits.
ASPs include all da Vinci models, all simulators, and Firefly when configure with the systems and exclude upgrades. Fourth quarter ASP's benefited from the favorable mix of dual console systems, Firefly enabled systems, and direct sales to Europe. ASPs will fluctuate quarter-to-quarter based on product, customer, and trade-in mix as well as foreign exchange rates on direct sales to international customers.
We sold 150 simulators during the quarter, mostly in conjunction with new system sales compared with 123 last year and 87 last quarter. We sold 32 dual console systems compared with 29 last year and 20 last quarter. 52 of our fourth quarter 2012 system sales involve trade-in comprised of 40 da Vinci S and 12 standard models. 50 of our fourth quarter 2011 sales all trade-in, and 34 of our third 2012 sales all trade-in.
Our recently launched Vessel Sealer product continues to pick up clinical momentum with most of the interest coming from colorectal, advanced general and GYN clinicians. The customer adoption for both da Vinci Simulator and Firefly continues to expand, with 115 customers purchasing a da Vinci Simulator and 88 customers purchasing Firefly systems, as part of their da Vinci purchase this quarter.
Lawrence S. Keusch – Raymond James Financial
Got it and then just two other quick ones, just relative to the 510 clearance that you guys are anticipating for Firefly in biliary, could you talk about how important that is to proceed the option of Single-Site Chole. It seems to me that obviously we can reduce kind of bile duct injuries that would be a positive with that technology. And then separately, I think last quarter you provided some feel for kind of in the U.S. what procedures grew if you were to adjust for the declines in prostatectomy. I was wondering if you can help us with that in the fourth quarter.
Gary S. Guthart
Just speaking to the first one, the 510(k) submission for Firefly biliary imaging that has just been submitted this quarter, so in terms of when we expect clearance, no end point to tell you about yet. We do think that biliary imaging in real time is interesting and meaningful for Cholecystectomy for the reason that you indicated that a common bile duct injury is a serious complication, and we think that Firefly can augment the white light imaging and be a complement to cholangiography, so that’s the intend. We‘ve just started that conversation with FDA and as it proceeds in we have something more material to share we will. With regard to the break outs on kind of the adjustments and the procedure mix, I’ll turn to Aleks.
Rick A. Wise – Stifel, Nicolaus & Co., Inc.
Okay. Japan, just again, I think you said a significant demand, with the da Vinci Si approval on hand, is this going to be an incremental driver or we’re going to see more upgrades maybe in 2013, getting help or bring that for us? Thank you.
Gary S. Guthart
I think there are really two things to say with regard to Si approval in Japan. The first one is we’re excited about the approval in large part, because it allows us to bring the Japan with follow-on clearances, a set of technologies that we think have really made a down set in the rest of the world and things like Single-Site and Firefly and thus assuming to counsel and simulate or a bunch of things that we invest on the SI system side. So we’re excited about that. I think structurally though in the longer term, the Japanese market penetration will be based by additional procedure reimbursement and so near-term it’s a great thing to get in the hands of Japanese customer. We need to continue to work on reimbursements beyond Prostatectomy and we will continue to do so.
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