In a development aimed at enhancing safety for all patients undergoing endovascular aneurysm repair (EVAR) of abdominal aortic aneurysms (AAA) and opening the clinical benefits of that minimally invasive procedure to millions of patients worldwide whose vascular anatomies are unsuited to the larger-diameter device in use today, Cook Medical has initiated enrollment in a U.S. clinical trial of its high-precision, next-generation Zenith® Low Profile AAA Endovascular Graft (Zenith AAA LP).
By reducing the diameter of the delivery system to 16 French and eliminating the need for a top cap to ensure precise delivery of the device to the target location within the patient’s aorta, the Zenith AAA LP represents a significant reinvention of Cook’s Zenith Flex AAA endograft system. If proven safe and effective, the new system could make EVAR possible for millions of AAA sufferers worldwide, particularly female and Asian patients who tend to have narrower, more tortuous vessels that current AAA endografts may have difficulty navigating safely.
Mark Farber, M.D., associate professor of surgery and program director of the vascular surgery fellowship at the University of North Carolina Hospitals, continues to pioneer the field of EVAR by performing the first successful placement in a U.S. patient of Cook’s low profile AAA endograft.
“While EVAR has become the preferred treatment method for AAA in most cases, patients with smaller vascular anatomies had few, if any, treatment options outside of highly invasive open surgery,” explained Dr. Farber. “With the new Zenith Low Profile AAA Endovascular Graft, physicians can now provide this challenging patient population with the solution of choice for treating AAA, which is the 13th leading cause of death in the United States. The Zenith LP AAA endovascular graft provides a low-profile delivery system and a simplified deployment procedure while maintaining the precision of the current Zenith Flex endograft. The Zenith LP creates more options for my patients that in the past could not have the endovascular procedure. The LP is building upon the tradition of technology innovation within the Zenith product line.”
AAAs affect approximately 200,000 Americans every year and occur when a section of the aortic wall, the body’s main blood vessel, weakens and creates a dangerous bulge that can rupture. When treated by open surgery, a large incision is made in the abdomen to allow a surgeon to clamp off the aorta and replace the damaged section with a surgical graft. This highly invasive method can lead to serious complications and extended recovery times. Conversely, during the minimally invasive EVAR procedure, an endograft is guided into the body by a catheter system to seal off the aneurysm from within. This treatment method usually results in a shorter recovery period and has a higher patient survival rate than open surgery.
“The first U.S. placement of the Zenith Low Profile AAA Endovascular Graft marks an important step by bringing minimally invasive treatment options to a broader set of patients worldwide,” said Phil Nowell, global leader of Cook Medical’s aortic intervention strategic business unit. “The new Zenith system is a major advancement in Cook’s endograft and delivery system technology. If approved, it will equip physicians with a superbly designed and crafted tool that offers the clinical benefits of Zenith, which is already the world leader in sales, with the advanced flexibility to treat a far larger subset of patients suffering from AAA using EVAR.”
Significantly smaller than most commonly used systems measuring 20-24 French, the Zenith Low Profile AAA system features a 16 French delivery sheath. Its size and simple delivery mechanism enable physicians in many cases to access the femoral artery percutaneously, without the surgical cut down currently needed. With this approach, a needle is inserted into the blood vessel through the skin, allowing the guide wire and delivery sheath to enter the artery with far less blood loss and trauma. The lower profile delivery sheath will also reduce the need for physicians to use more invasive conduits, surgical bypass grafts, to gain aortic access in patients with advanced atherosclerosis.
Dr. Farber’s initial procedure at UNC kicks off the device’s clinical trial in the U.S., which is evaluating the safety and effectiveness of the small endograft delivery system in 120 patients at 24 trial sites. Dr. Farber receives financial support from Cook to educate physicians in the proper use of the Zenith endograft system. Ronald Fairman, M.D., chief of vascular surgery and endovascular therapy at the University of Pennsylvania in Philadelphia, Penn., serves as the trial’s principal investigator. The Zenith® Low Profile AAA Endovascular Graft is an investigational device not approved for sale in the United States.
Source: Cook Medical