PQ Bypass Reports Positive 12-Month Results for New Procedure to Treat Extremely Long SFA Lesions

Results from the DETOUR I Trial evaluating the PQ Bypass DETOUR System for percutaneous bypass showed promising 12-month durability for patients with extremely long blockages in the superficial femoral artery (SFA). The trial enrolled lesions longer and more complex than those typically studied in SFA clinical trials, with an average lesion length of 37cm, 100 percent TASC II C/D, 96 percent chronic total occlusions (CTO), and 81 percent with moderate-to-severe calcification.
 
The DETOUR I trial, a prospective, single-arm, multicenter, core lab-adjudicated study, enrolled and treated 77 patients and 81 lesions. Primary and primary-assisted patency at 12 months in all lesions of the DETOUR I trial was 73 percent and 80 percent, respectively. Secondary patency was achieved in 94 percent of patients. Additional safety and effectiveness outcomes include 100 percent freedom from amputation, 99 percent freedom from acute limb ischemia, and Rutherford improvement of ≥ 2 classes in 90 percent of patients.
 
“The lesions treated in DETOUR I were more than just long, they were extremely long, completely blocked, and severely calcified,” said Dainis Krieviņš, M.D., Ph.D., vascular surgeon and director of the Institute of Research at Pauls Stradins Clinical University Hospital. “Endovascular devices currently approved for use on these incredibly challenging lesions have surprisingly low durability in lesions that are half the size of the average DETOUR lesion and fail approximately 40 percent of the time by the 12-month milestone. This truly highlights the need for the minimally invasive DETOUR procedure for long, complex SFA lesions.”
 
Percutaneous femoropopliteal bypass (the DETOUR procedure) is an entirely new procedure enabled by PQ Bypass’s proprietary DETOUR System. The DETOUR procedure creates a pathway with PQ Bypass’s proprietary stent grafts, originating in the SFA, traveling through the femoral vein, and ending in the popliteal artery, bypassing the diseased part of the artery. The stent grafts re-direct oxygen-rich blood around the blockage, restoring blood flow to the lower leg and foot of the patient.
 
“These results represent exciting promise for patients with long, complex SFA lesions, a growing, yet severely underserved population,” said Heather Simonsen, vice president of Global Therapy Development at PQ Bypass Inc. “By routing blood around the disease, rather than forcing a way through it, the DETOUR System is designed to treat extremely long lesions that are not well-addressed by current endovascular devices. We look forward to continuing the collection of clinical data in our US IDE to build upon the outcomes observed in DETOUR I.”
 
Peripheral artery disease or PAD, is a common circulatory condition wherein adequate blood flow does not reach the limbs due to a build-up of fatty deposits and calcium on the artery walls. One in five adults over the age of 60 in the United States have PAD, and more than $4 billion a year is spent on PAD-related treatment within the United States.¹ When this disease reaches an advanced stage within the superficial femoral artery and the popliteal artery, it develops into femoropopliteal occlusive disease.
 
The DETOUR II trial is the first pivotal investigational trial in the United States for percutaneous bypass and is currently enrolling. The trial will enroll up to 292 patients at up to 40 sites across the United States and Europe, and is led by national co-principal investigators Sean Lyden, M.D., FACS and chairman of the Department of Vascular Surgery at the Cleveland Clinic, and Jihad Mustapha, M.D., FACC, FSCAI, CEO and vascular surgeon at Advanced Cardiac and Vascular Amputation Prevention Centers. The DETOUR II trial aims to expand the body of evidence evaluating the safety and effectiveness of the DETOUR System to create a percutaneous femoropopliteal bypass.
 
PQ Bypass Inc. is a Silicon Valley-based medical device company developing the DETOUR procedure for percutaneous femoropopliteal bypass. Its proprietary DETOUR System is a physician-driven innovation, created by Dr. James Joye and Dr. Richard Heuser, world-renowned experts and pioneers in the treatment of PAD. In March 2017, PQ Bypass received CE Mark approval for the DETOUR System. In August 2017, Frost & Sullivan recognized PQ Bypass with the 2017 European PAD Interventions Technology Innovation Award for the DETOUR procedure.
 
The DETOUR System is limited to investigational use only.
 
Reference
1. Hirsch, Alan T., Lacey Hartman, Robert J. Town, and Beth A. Virnig. “National health care costs of peripheral arterial disease in the Medicare population.” Vascular Medicine 13, no. 3 (2008): 209-215.