First GORE HELEX Septal Occluder Workshop a Success

In June, Gore sponsored its first ASD closure workshop in the United States, featuring the GORE HELEX Septal Occluder. The workshop was held at the historic Omni Parker House Hotel in downtown Boston, Massachusetts. Nearly 40 physicians were in attendance during this two-day event.

Led by a faculty consisting of Igor Palacios, MD (Massachusetts General Hospital, Boston, Massachusetts), John Rhodes, MD (Duke University Medical Center, Raleigh, North Carolina), Neil Wilson, MD (John Radcliffe Hospital, Oxford, United Kingdom),
and Ignacio Inglessis, MD (Massachusetts General Hospital, Boston, Massachusetts), the workshop exposed attending physicians to a thorough review of the device's features and benefits, clinical data, hands-on demonstrations, and several case examples highlighting the GORE HELEX Septal Occluder and providing imaging examples of the device.

Additionally, two ASD live cases were broadcast into the meeting room. These cases were conducted by Robert Sommer, MD from Columbia Presbyterian Hospital in New York, New York. Participants were provided the opportunity to interact with Dr. Sommer throughout the cases, and as with all the workshop's sessions, questions were encouraged.

Here is some of the feedback we received from physicians attending this inaugural event:

• "The workshop was instructive and insightful."
• "Very good course, helping me to improve my practice."
• "Good overview of the GORE HELEX Device - usage and limitations. Excellent opportunities for discussion and questions."
• "Overall, an excellent workshop."

As noted in the Upcoming Events section of this newsletter, two additional workshops are scheduled over the next few months - one in Seattle, Washington and the other in Chicago, Illinois. If you are interested in attending either of these events, please contact your local Gore Sales Associate for details.

Learn more about the GORE HELEX Septal Occluder at goremedical.com/helex.

REDUCE Clinical Study: A New Investigational Study for PFO Stroke Patients That's Like No Other

The last several years have shown that achievement of a Patent Forman Ovale (PFO) stroke indication in the US is a daunting challenge. Off-label use, physician and patient bias, and a lack of consensus about the choice of medical therapy have contributed to the slow enrollment rates of these studies. It is time for a modernized approach.

The recent approval of the Gore REDUCE* Clinical Study offers a new investigational alternative for the prevention of recurrent cryptogenic stroke.

A unique randomization approach provides a greater probability for patients to receive device closure in this study. Together with the involvement of centers within the Nordic countries, these attributes will drive enrollment. Imaging confirmation of the primary endpoint, as well as consistency in prescribed medical therapy across treatment arms, will additionally bolster the data and assist the interpretation of results.

Patients randomized to the device arm of the Gore REDUCE Clinical Study may receive the GORE HELEX Septal Occluder. Previously approved for closure of ostium secundum atrial septal defects, this device is now being investigated for PFO closure.

Patients are now being sought for participation in the Gore REDUCE Clinical Study. Eligible participants will have been diagnosed with a cryptogenic stroke or imaging-confirmed transient ischemic attack (TIA) and have been diagnosed with a PFO. Additional inclusion and exclusion criteria will be applied to prospective patient enrollment.

Investigating alternatives for the prevention of cryptogenic stroke is a challenge like no other. And no company is better equipped to accept that challenge than Gore.

Caution: Investigational Device. Limited by United States Law to Investigational Use for the Indication Described in this Ad.

* REDUCE: GORE HELEX Septal Occluder plus Antiplatelet Medical Management for Reduction of Recurrent Stroke or Imaging-Confirmed Transient Ischemic Attack (TIA) in Patients with Patent Foramen Ovale (PFO).