EVEREST clinical trial results to be presented at the upcoming TCT Conference

Sep 16 2009

The upcoming Transcatheter Cardiovascular Therapeutics (TCT) Conference, to take place in San Francisco from September 21-25, will serve as a backdrop for the presentation of EVEREST registry clinical results of the MitraClip(R) therapy for patients with mitral regurgitation (MR). MR is the most common type of heart valve insufficiency in the United States and Europe, and affects millions of people worldwide. The MitraClip(R) therapy provides a non-surgical treatment option for patients suffering from the effects of functional or degenerative MR.

Among oral presentations at TCT 2009, EVEREST investigators as well as independent physicians will report data related to the clinical impact of reduction of MR and the histopathology of the MitraClip(R) device collected as part of the EVEREST registry studies. The data are from the preliminary cohort of the first 107 patients as well as from patients enrolled in the high risk registry. Other presentations at TCT 2009 will discuss the EVEREST study design, procedure simulation and clinical outcomes of patients treated in Europe following CE Mark.

Highlights of the data to be presented at TCT 2009 include:

Tuesday, September 22

• "Successful MitraClip(R) Therapy Results in Favorable Sept-Lateral Mitral Annular Diameter and Left Ventricular Remodeling"; Saibal Kar, M.D. will present 12-month results of functional MR patients from the EVEREST II High Risk Registry arm on Tuesday at 10:15 a.m. in room 113.
• "Long-Term Histologic Response Following MitraClip(R) Implantation"; Renu Virmani, M.D. will present data on the healing response in patients from the EVEREST I and EVEREST II trials from 301 to 1878 days after treatment on Tuesday at 11:15 a.m. in room 113.
• "Significant Reverse Left Ventricular Remodeling One Year After Successful MitraClip(R) Therapy"; Scott Lim, M.D. will present 12-month data reporting reverse remodeling in patients from the initial EVEREST patient cohort on Tuesday at 11:00 a.m. in room 113.
• "Mitral Regurgitation: Percutaneous Edge-to-Edge Evalve MitraClip(R) System Session" several presentations about the MitraClip(R) therapy will take place from 4:47-6:30 p.m. in room 135.

Thursday, September 24

• An overview of a MitraClip procedure will be presented by Dr. Lim on Thursday at 2:30 p.m. in the main arena. During the same session Marty Leon, M.D. will demonstrate the MitraClip(R) Virtual Procedure, a unique computer-based procedure simulation system under development.

Evalve's European Commercial Pace Continues to Grow

More than 200 patients have been treated with the MitraClip(R) system in Europe. The MitraClip(R) system is the only medical device commercially available in Europe to provide a non-surgical treatment option for patients suffering from the effects of functional or degenerative MR. As of today patients have been treated with the MitraClip(R) system at 19 institutions throughout Europe.

Evalve initiated commercial sales of the MitraClip(R) system in Europe under the CE Mark in September 2008. The company is employing a direct sales strategy and is taking a disciplined and measured approach to the initial commercial roll out. The company has worked closely with hospitals to deliver high quality training programs to cardiologists and cardiac surgeons in preparation for the first series of implants.

Additional U.S. Clinical Trial Milestone Reached

Evalve also announced today that the last U.S. patient treated in the EVEREST II randomized study has reached the required 12-month follow up. Clinical results from the study are not yet available and will be released in 2010.

Meanwhile, enrollment in REALISM, the continued access registry, continues to be strong with 120 patients treated as of September 1st 2009.

"The science that will be presented at this year's TCT conference contributes significantly to the broad body of clinical data shedding light onto the importance of breakthrough structural heart disease therapies like the MitraClip(R) system," said Ferolyn Powell, president and chief executive officer of Evalve. "The Clinical results to date underscore the acute clinical benefit for patients, demonstrate the potential for reduced hospital stays and improved quality-of-life for patients, and the potential for delivering significant health economic benefit in medical care systems around the world. Additionally, reaching important milestones such as treating 200 patients in Europe and our success with the REALISM registry highlights the belief physicians have in the value of this new therapy for their patients whether their specialty is cardiology or cardiothoracic surgery."