Houston, TX (January 24, 2017) – St. Luke's Health–Baylor St. Luke's Medical Center (Baylor St. Luke's) announced today that it is the first hospital in Houston to participate in a new FDA-approved clinical trial designed to test the MANTA™ Large-Bore Vascular Closure Device. The device is intended for use in closing access sites on the femoral artery for percutaneous procedures, including transfemoral transcatheter aortic valve replacement (TAVR), endovascular aortic repair (EVAR) of abdominal aortic aneurysms (AAA), ventricular assist devices (VAD), thoracic endovascular aortic/aneurysm repair (TEVAR), and balloon aortic valvuloplasty (BAV).
“I'm very excited to be a part of the MANTA vascular closure trial as I believe it will deliver fewer complications and faster overall procedure times,” said Zvonimir Krajcer, MD, Co-Principal Investigator of the U.S. MANTA trial and Program Director, Peripheral Vascular Interventions, Texas Heart® Institute (THI) at Baylor St. Luke's. “Until now, we've had to use vascular closures devices that were not originally designed for EVAR, TEVAR, and TAVR. For the first time, we finally have the opportunity to use a reliable and simple vascular closure device for large bore sheaths. This device is also a safety advancement in the treatment of aortic aneurysmal and valvular heart disease as it is designed to address the complexities of closing large punctures in high-pressure vessels.”
How MANTA Works
Large bore procedures are the fastest growing segment of the cardiovascular market. Closure of large bore femoral access sites is historically associated with significant increases in morbidity including longer times to achieve hemostasis, extended procedure times, higher rate of complications, and higher total cost of care. In an effort to address these complexities of closing large punctures in high-pressure vessels, this novel device is designed to close punctures ranging from 10F-24F in less than one minute, providing immediate hemostasis through an “anchor/plug” sealing technology that encompasses common absorbable biomaterials, fluoroscopic visibility, and deployment force control. The device comes in two sizes (14F and 18F) to achieve this range.
First Case In Houston
During the first Houston procedure, Dr. Krajcer used the first large-bore closure device in conjunction with an Ovation iX to treat an AAA patient with a chronic dissection that spanned from low renal to approximately 10mm distal. Under local anesthesia and performed with the percutaneous (without incision) approach, Dr. Krajcer made the decision to cover and protect the dissection area with a sealing collar and standard implant. The femoral artery access site was successfully repaired with 14F MANTA vascular closure and established immediate hemostasis. After the procedure, the patient was able to get out of bed six hours after the procedure and was discharged the next morning from the hospital in satisfactory condition.
“Through clinical trials such as this one, we continue to advance the field of minimally invasive surgery and test new, innovative techniques that improve medical outcomes for AAA and related conditions,” said Dr. Krajcer.
About St. Luke's Health
St. Luke's Health, a member of Catholic Health Initiatives (CHI), is comprised of three markets St. Luke's Health is home of the Texas Heart Institute (THI), eight hospitals, eight emergency centers, Diagnostic & Treatment Center, Radiation & CyberKnife® Center, and several St. Luke's Medical Group locations throughout Greater Houston; St. Luke's Health Memorial (three hospitals and a long-term acute care facility in East Texas); and St. Joseph Health (five hospitals and several St. Joseph Medical Group locations across Brazos Valley). In addition, St. Luke's is a part of a joint venture agreement with Baylor College of Medicine®, which encompasses Baylor St. Luke's Medical Center in the Texas Medical Center. Together, St. Luke's Health, THI, and Baylor College of Medicine® are transforming healthcare delivery with a mission to usher in a new era of healthcare to create healthier communities. For more information, visit CHIStLukesHealth.org.
St. Luke's Health is a part of Catholic Health Initiatives (CHI), one of the nation's largest health systems. Headquartered in Englewood, Colorado, CHI operates in 19 states and comprises 105 hospitals, including four academic medical centers and teaching hospitals; 30 critical-access facilities; community health services organizations; accredited nursing colleges; home health agencies; and other services that span the inpatient and outpatient continuum of care. Learn more at catholichealthinitiatives.org.