Michael Carrel
Analyst · Piper Jaffray
Thanks, Lynn. Good afternoon, everyone, and thank you for joining us. We are off to a solid start in 2018. Total revenue for the quarter was $47 million reflecting growth of 14% over the first quarter of last year. Our top line performance was largely driven by the strength of our U.S. open and appendage management products, with our appendage management franchise continuing to demonstrate significant and meaningful growth. We are reiterating our 2018 revenue expectations for year-over-year growth of 9% to 12%. In addition to strong first quarter sales, we had solid enrollment in the CONVERGE trial, and we're confident in our ability to complete enrollment in this important clinical trial in the very near future. Turning to our product pipeline and platforms, we are continuing to build our portfolio with products that expand our reach and impact worldwide. This is particularly evident in our appendage management franchise, formerly referred to as the AtriClip franchise. Recent launches of the AtriClip PRO V and FLEX V products have driven expansion into new accounts, and importantly, they have maintained strong pricing due to the incremental value they bring to clinicians. Since its launch last year, the AtriClip PRO V device has been highly additive to our product portfolio. As you may recall, the AtriClip PRO V offers an open-ended design combined with a tip-first closure mechanism to enable easier navigation and placement when operating in a minimally invasive procedure. It is also 1/3 of the height profile of the original AtriClip device. So it is easier to visualize during placement. Experience and feedback continues to be overwhelmingly positive, with the AtriClip PRO V going into many new accounts in the first quarter. We expect increasing contribution from AtriClip PRO V as the year progresses. Further building on the AtriClip platform, we received FDA clearance of the AtriClip FLEX V device in February and subsequently launched in early March. The AtriClip FLEX V is our next-generation open-chest AtriClip device, which leverages the same technology we developed for the AtriClip PRO V. This includes a lower profile implant, an easier-to-use delivery system and a trigger release deployment mechanism, the first of its kind in the AtriClip family. We believe that the AtriClip FLEX V device will help us grow adoption of the left atrial appendage management in our open procedures. In a few short weeks, we have already seen many new customers adopt the AtriClip FLEX V. As we look to our pipeline, the V-shaped AtriClip platform is the foundation of our development efforts and future innovation, which utilize increasingly less invasive applications for the left atrial appendage management. We continue to make significant advancements in this area and anticipate launching the AtriClip PRO X device for sub-xiphoid applications in early 2019. The AtriClip PRO X device will provide the benefit of excluding the LAA through the same sub-xiphoid incisions used to perform the convergent ablation procedure. In the area of clinical science, we also continue to make important and meaningful progress. The CONVERGE trial remains our top priority. We are currently at 124 patients enrolled across 25 sites, and we are confident in our ability to complete enrollment of the full 153 patients in line with our midyear goal. We also expect to complete enrollment in the FROST trial, in the second half of the year. We have started reenrolling patients in DEEP, and we continue to work collaboratively with the FDA to obtain final clearance to move forward for full enrollment of the trial. As most of you know, we remain well positioned as a leader in the market to address the many Afib patients, who too often go untreated in a concomitant setting. We expect the meaningful activities of education and training and the data from leading medical institutions and societies will ultimately influence care and support growing procedural volumes. The clinician community is increasingly recognizing the benefits of surgical ablation and the downside of non-treatment, and we are well positioned to take advantage of these market tailwinds. On the training and educational front, we have training sessions planned throughout - through 2018, both in the U.S. and Europe. Even after many years, we are encouraged by the strong interest in our courses. They quickly fill up and have prompted the addition of significantly more hands-on programs. We remain committed to working towards improving adoption of surgical ablation in a concomitant setting. You may have seen the save-the-date notice for upcoming analysts meeting on the morning of June 26 to discuss in more detail our product pipeline, our clinical trial progress and the trends driving our business. 3 leading physicians will offer their perspective on broad market opportunity with specific focus areas. Dr. Marc Gillinov, a thought leader in the industry, is the Chairman of the Department of Thoracic and Cardiovascular Surgery at Cleveland Clinic and Surgical Director of the Center for Atrial Fibrillation at Cleveland Clinic. He will cover broad trends in cardiac surgery, the treatment paradigm for open procedures and the recent guidelines, including why treatment is important during concomitant cardiac surgery. Dr. Gillinov has an extensive experience with our appendage management products as well as other products and he will share his thoughts on the importance of treating the left atrial appendage. Dr. David DeLurgio is an electrophysiologist at Emory and our principal investigator for the CONVERGE trial. Dr. DeLurgio will cover why EP and surgeon collaboration drives better care and why a team approach to Afib is important. As a CONVERGE trial PI, he is uniquely positioned to provide deeper insights into our clinical trial and what it means for care over the long term. And finally, Dr. Marc Gerdisch is the chief of cardiovascular and thoracic surgery and co-director of the Heart Valve Center and Atrial Fibrillation program at Franciscan St. Francis Health. Dr. Gerdisch has been a key physician trainer for more than 3 years and has also been a lead investigator and the highest enroller in both our AtriClip PRO V and ATLAS studies as well as our postapproval study to ablate. He will share his experience as a trainer and his views on how collaborative approach can provide greater access to the care for Afib patients. We are looking forward to an insightful and productive morning, and we hope that you can join us either in person or via webcast. With that, I will now turn the call over to Andy Wade, our Chief Financial Officer, then we'll return for closing comments.