Cook Medical (Bloomington, Indiana) yesterday reported commercial launch of its Surgisis Biodesign Umbilical Hernia Graft, a device it bills as a “unique” solution for umbilical hernia repair.

The device, which received FDA clearance last fall, is designed to specifically fit the patient’s individual anatomy. The company said it has not yet received the CE mark for the device, but that that CE-marking is expected next quarter.

“Most of the patients that this device services are heavier patients – or those suffering with hernias that have poor tissue recuperation,” Chris Nelson, global product manager for Cook, told Medical Device Daily.

“But it isn’t limited [in use] just to people who are obese. It also is [for] to women who have given birth – or weightlifters – anyone who puts a tremendous strain on their abdomen, or who could be at risk for a hernia. Mostly general surgeons would be the primary market for this device, although some in the OB/GYN [field] could also use the Umbilical Hernia Graft.”

Umbilical hernias occur when part of the intestine protrudes through a weak spot in the abdominal muscles at the navel. The bulge typically ranges from 1 to 5 cm in diameter. Although painless in children and infants, umbilical hernias that appear during adulthood can cause severe abdominal discomfort. they can be caused by obesity, heavy lifting, coughing, multiple pregnancies and fluid in the abdominal cavity.

The Umbilical Hernia Graft is a small circular-shaped device that contains hole-like structures on its periphery. The patterns of these holes serve as guiding points for the surgical placement of sutures, according to the company.

“There’s a unique positioning of the sutures” for this treatment, Nelson said. “If you can picture a clock, there are four points that are in the direction of 12, 3, 6, and 9. This serves as a visual guide for surgeons.”

The device is carefully opened below (never over) the defect, extending somewhat beyond the under edges of the hernia “hole” itself. This immediately, safely and securely repairs the hernia, the company says.

Additionally, and importantly, the device acts as a bridge or scaffolding for in-growth of new tissue to broadly support the abdominal wall muscle. In the process, the device becomes incorporated into the muscle layer. No muscle is cut, nor is it ever sutured together to create unnecessary or unwanted tension.

The company says that the device is extremely thin and very flexible and therefore is undetectable to the patient, both during normal day-to-day activity as well as during more aggressive physical and recreational activities.

“It is strong enough to fully and effectively repair the hernia, such that our patients are fully able to resume normal activity without undue concern for recurrence,” according to a statement by Cook.

It says the device’s design provides a tailored treatment that helps create functional, living tissue and restores the natural form and function of the body. Patients experience a quick recovery and can typically return to their normal, daily activities within two to three weeks after surgery, Cook say.

“In all, you’re talking about probably a 15-minute procedure for the placement of the device,” Nelson said. “I think the overall goal for this device is to stop reoccurrence rates for hernias and to not cause any additional damage to the patient.”

According to an article on the website of the North Penn Hernia Institute (Lansdale, Pennsylvania), current standard techniques attempt to repair these hernias by simply closing the muscle defect with sutures that place the muscle tissue under significant tension. Often in this older method, muscle layers are overlapped.

Such suturing, however, recreates the muscle layer tension that originally created the hernia defect, and also often weakens adjacent tissue layers as well. This can lead to unnecessary pulling of the tissues at the hernia area.

The Surgis is designed to avoid these problems.

Cook’s Surgis Biodesign product line provides treatments for several procedural areas, including hernia repair, plastic and reconstructive/ENT, staple line reinforcement, Peyronie’s repair, continence restoration, dural repair and pelvic floor repair.

In other news from Cook:

The company reported the enrollment of the first patient in the STABLE clinical trial used to evaluate the company’s Zenith Dissection Endovascular System for the treatment of Type B thoracic aortic dissections.

Thoracic aortic dissections are tears in the wall of the aorta that cause blood to flow between the layers of the wall of the aorta and force the layers apart. Cook said FDA approval to begin the three-center U.S. Phase I trial was granted last fall (Medical Device Daily, Oct. 1, 2007).

The company says that the device is the “first of its kind” and designed specifically to treat aortic dissection.

The Dissection Endovascular System looks a bit like a thin-wire slinky, covered in a cloth-like mesh. It is intended for use in the endovascular treatment of descending thoracic aortic dissection, the company providing the qualification that it is used only “in patients with anatomies appropriate for endovascular repair.”

Physicians insert a catheter loaded with the self-expanding stent-graft (called the TX2) through a surgical opening in the femoral artery. The catheter is then guided through the patient’s blood vessels under fluoroscopy until the device is positioned across the weakened section of the aorta.

The stent-graft expands upon deployment from the catheter to form a continuous tube through the aorta that carries the blood and reduces pressure on the damaged vessel, restoring normal blood flow. The uncovered Zenith Dissection Stent may be used to expand the true lumen in the distal thoracic aorta where preservation of the side branch artery blood flow is critical.

In essence, the TX2 Stent Graft repairs the primary entry tear while the bare metal dissection stents were placed to expand and support the remainder of the dissected aorta for the length of the dissection (in this case to the level of the aortic bifurcation).

The company said that it hopes for completion of Phase I STABLE within six months, hopefully garnering FDA approval by 2010.