First Live Transmission of EXCITE ISR Procedure Seen at NCVH

LAFAYETTE, La. - June 20, 2013 - PRLog -- The first live transmission of an EXCITE ISR clinical trial case was seen on Wednesday, June 5, 2013, by more than 1,500 attendees in attendance at the New Cardiovascular Horizons (NCVH) conference. Study operators received permission from the FDA to broadcast the procedure, performed by Carlos Mena, MD, at Yale-New Haven Hospital, New Haven, Conn., into the ballroom at the New Orleans Marriott.

Dr. Mena performed the procedure on a 65-year-old male patient who had recurring claudication symptoms over the past six months. He shared information on the study protocol with the audience as he performed the procedure, which was determined to be a success.

Eric Dippel, MD, principal investigator, EXCITE Trial, served as moderator for the live case panel. “In-stent restenosis (ISR) is a major problem –there are a lot of people with stents out there,” he explained. “There isn’t a FDA-approved device to treat ISR. We hope to gain FDA approval and show that it is safe and effective.”

Drs. Mena and Dippel both agreed that NCVH attendees benefited from viewing a live case procedure that showcased the benefits of laser angioplasty, as compared to to performing the same procedure using a balloon.

“It’s helpful for the audience to see what we are doing,” said Dr. Dippel. “I don’t know how many have seen a laser case before.”

The benefits of using the laser include ease of use and easy to set up.

“We are optimistic that the laser will be better than the balloon,” said Dr. Dippel. “This is a landmark study.”

This procedure was one of 32 live case transmissions viewed by attendees during the three-day conference. Live cases were broadcast from eight sites, including two international institutions.

About the EXCITE ISR TRIAL
The purpose of the EXCITE ISR TRIAL - EXCImer Laser Randomized Controlled Study for Treatment of FemoropopliTEal In-Stent Restenosis – is to evaluate the safety and efficacy of the Spectranetics Excimer Laser Atherectomy (ELA) with adjunctive percutaneous transluminal angioplasty (PTA), compared to PTA alone, in the treatment of subjects with chronic peripheral arterial disease (PAD), Rutherford Class 1-4 associated with femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents, in vessels ≥5.0mm. Visit http://www.spectranetics.com/patients/pad-peripheral-arte... for more information.

About NCVH
New Cardiovascular Horizons (NCVH) is a peripheral intervention conference focusing on peripheral artery disease (PAD) with a special emphasis on critical limb ischemia (CLI). The goal of NCVH is to bring together key disciplines to focus on the team approach to total cardiovascular care in patients with PAD and CLI. This approach creates an environment for clinical collaboration to address the continuum of care for the patient. NCVH is hosted annually in New Orleans and is well known for hospitality and a family friendly environment. NCVH 2014 is scheduled for May 28-30, 2014. Visit www.ncvh.org to learn more.

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For more information about NCVH, to request images or to be connected with Drs. Dippel or Mena, please contact NCVH headquarters at (337)993-7920 or dana.rigdon@slcrf.org.