October 6, 2020
PQ Bypass Completes Enrollment in DETOUR2 Study and Names Heather Simonsen as President
October 6, 2020—PQ Bypass announced the completion of enrollment in the DETOUR2 clinical trial, the company’s investigational device exemption trial of the Detour system for percutaneous femoral-popliteal bypass in patients with extremely long, complex lesions in the superficial femoral artery (SFA).
According to PQ Bypass, the prospective, multicenter DETOUR2 trial enrolled 202 patients at 36 sites in the United States and Europe. The trial is assessing freedom from major adverse events within 30 days of the index procedure as the primary safety endpoint. The primary effectiveness is primary patency at 12 months.
DETOUR2 is led by National Co-Principal Investigators Sean Lyden, MD, and Jihad Mustapha, MD.
“The speed with which we were able to enroll DETOUR2 in 2020 speaks to the large patient population that exists with long-segment femoropopliteal disease that has suboptimal endovascular options,” commented Dr. Lyden in the company's announcement.
Dr. Mustapha, added, “If percutaneous fem-pop bypass is shown to be safe and effective, similar to the outcomes demonstrated in DETOUR1 study, it could be a game-changer for the way we treat complex, long-segment SFA disease today.”
The company recently announced it had received Breakthrough Device designation from the FDA for the Detour system.
In other company news, on October 2, PQ Bypass named Heather Simonsen as its President and announced the appointments of Marion Larrea as Vice President of Operations and Colleen Holthe as Vice President of Clinical Affairs.
On the appointment of Heather Simonsen as President, the company’s Chairman of the Board and CEO Rich Ferrari stated, “With almost 30 years of health care experience and a proven track record of success leading organizations in both early- and late-stage ventures, Heather is uniquely qualified to guide the future strategic direction of PQ Bypass. The Board and I are confident that the leadership she has demonstrated at PQ Bypass over the past 4 years, combined with her extensive knowledge of the peripheral intervention space, will be invaluable as we move into our premarket stage for not one, but two premarket approval submissions.”
According to the company, Simonsen has held senior leadership roles for both venture-funded medical technology startups and Fortune 500 companies such as Abbott and Johnson & Johnson. She spent the early part of her career in hospital administration and management consulting with a specialty focus on risk management for health care organizations.
Additionally, she serves on the Founders Board of Advisors for the StartX incubation program for entrepreneurial companies focused on changing the future of health care at Stanford University in Stanford, California. Simonsen was a founding board member for the Healthcare Businesswomen’s Association (HBA) in San Francisco, California. She served on the HBA national Board of Directors and on the board of the Medical Marketing Association.
Simonsen earned an MBA from the DePaul University’s Kellstadt School of Business in Chicago, Illinois, and completed the Executive Program at Dartmouth College’s Tuck School of Business in Hanover, New Hampshire.
“I am proud and honored to be appointed to the role of President of PQ Bypass, and look forward to further advancing our mission to develop new options for patients with complex PAD,” said Simonsen.