LEOMINSTER, Mass.– The Vascular Care Group (TVCG), a state-of-the art practice committed to the prevention, diagnosis and treatment of vascular disease, today announced Stephen J. Hoenig M.D. successfully completed a percutaneous femoral-popliteal artery bypass at the Leominster, Mass. location of TVCG, marking one of the first such procedures in an outpatient setting in the state. TVCG has centered its treatment model around optimizing the patient experience, providing advanced vascular interventions outside of the traditional hospital setting, and mitigating unnecessary expense. The success of this cutting-edge, minimally invasive procedure marks another step toward that mission.
The procedure was part of an investigational device exemption (IDE) trial called DETOUR2 Continued Access (NCT04625660), sponsored by Endologix LLC. The trial is evaluating the safety and effectiveness of the PQ Bypass System for a percutaneous femoral-popliteal bypass procedure. The PQ Bypass System was designated as a U.S. Food and Drug Administration (FDA) Breakthrough Device in 2020.
“By offering this type of minimally invasive procedure in the outpatient setting, we can help patients avoid a surgical incision, hospitalization and postoperative recovery,” said Dr. Hoenig. “The patient was discharged two hours after the procedure with no discomfort and only two small, quarter-inch access incisions. This clearly changes our approach to limb threatening disease. I feel privileged to be one of the first vascular surgeons in Massachusetts to perform the procedure.”
Dr. Hoenig performed the procedure in his Leominster vascular center. The patient was placed under light conscious sedation and was sent home to recover a few hours later. This advancement in treatment was performed in concert with Vascular Breakthroughs, a clinical trials management platform.
“This is an impressive achievement for both Dr. Hoenig and The Vascular Care Group,” said Dr. Paul Gagne, founder of Vascular Breakthroughs, the clinical trials research organization supporting Dr. Hoenig. “The procedure expands the possibilities of vascular care in the outpatient setting and provides patients with better outcomes in a patient-friendly environment.”
The percutaneous bypass graft is used to restore blood flow to the lower leg and foot using a minimally invasive technique that avoids hospitalization and long recovery. With this new procedure, The Vascular Care Group is providing new technologies and techniques to community physicians working outside of large research centers, enabling greater access to medical innovation in a safe, efficient, patient-friendly setting. It marks another step in granting communities access to cutting-edge technology on a local level at a lower cost, without requiring a trip to a major city, or a long hospital stay.
The PQ Bypass System is limited by federal law to investigational use only and is not available for sale.
