Abdominal Surgery

2 MILLION

ABDOMINAL SURGERIES / YEAR IN UNITED STATES

2.5 MILLION

ABDOMINAL CLOSURES

(LAPAROTOMIES)

500,000

VENTRAL HERNIA REPAIRS

Ventral Hernias

There are ~500,000 ventral hernia repairs each year in the U.S. alone. This condition often can develop after abdominal surgery. It occurs when part of an internal organ or abdominal tissue protrudes through the abdominal wall. This represents one of the most frequent operations performed by a general surgeon. TAS seeks to address several problems in the ventral hernia space.

The need for minimally invasive solutions. 75% of ventral hernias are repaired using an open surgical approach. These open surgeries often require that a patient stay in the hospital for 5-7 days to recover. The minimally invasive approach (laparoscopic) has been proven to significantly reduce length of stay and other surgical complications. TAS seeks to enable ventral hernia procedures to be performed as minimally invasive surgery and save our healthcare system hundreds of millions of dollars each year.
The need for a more durable repair. Ventral hernia is a chronic condition that often requires mesh to reinforce the use of sutures. Literature shows that when sutures are used alone, the reoccurrence of hernia is 43% compared to that of 24% when mesh is added. Sutures are failing! TAS was designed with the intent to reduce hernia re-occurrence with our five-step kit and surgical grade zip straps.
The complications of Mesh. Mesh is used in 95% of all ventral hernia repairs. Mesh carries with it a risk of infection which can cause significant, complications, expense to hospitals and litigation to our healthcare system.

N Engl J Med 2000; 343:392-398
DOI: 10.1056/NEJM200008103430603A Comparison of Suture Repair with Mesh Repair for Incisional Hernia

A Comparison of Suture Repair with Mesh Repair for Incisional Hernia | NEJM

Laparotomies are performed

for a variety of reasons.

Trauma Surgery

Bowel Surgery

Exploratory Surgery

There are ~2 million instances each year in the United States that a surgeon goes into the operating room to close an abdominal incision.

Sutures are used to close these incisions and they are prone to failure. Sutures can break, or their knots can loosen and unravel. Because of their small diameters, sutures can also tear through tissue and create a "cheese wire" effect. For these reasons, surgical wounds don't always stay closed. When the incision opens soon after abdominal closure, it is a condition called dehiscence. Dehiscence is a serious problem.

Cost of dehiscence: *

Increased mortality by 9.4%
Increased hospital length of stay by 9.6%
Increased hospital expenses by $40,000

TAS seeks to reduce the burden of dehiscence with our atraumatic surface area and larger diameter zip strap. Our strap is 3X stronger than the sutures used during abdominal closure, and it maintains a larger atraumatic surface area.** TAS also offers the opportunity to simplify closure and reduced procedure time.

Laparotomies

*JAMA 2003 Oct 8;290(14):1868-74. doi: 10.1001/jama.290.14.1868.

Excess length of stay, charges, and mortality attributable to medical injuries during hospitalization

**DATA ON FILE: TAS Medical Inc. Tensile strength comparative, 3X strength of polypropylene

The Tissue Approximation System (TAS) is intended for use in soft tissue approximation, including use in general surgery procedures such as minimally invasive ventral hernia and abdominal wall closure . . .

Contraindications
Due to the gradual loss of tensile strength which may occur over prolonged periods in vivo, the zip-tie, comprised of nylon, should not be used where a permanent retention of tensile strength Is required.
The TAS is not indicated for surface closures through the epidermis as the size of the zip-tie makes it unfeasible.

Warnings and Precautions

Do not use if the patient may experience an allergic reaction to polyamide (nylon).
The Tissue Approximation System (TAS) contains sterile, single-use devices. Discard after single use. Discard in accordance with accepted medical practice and applicable local, state, and federal laws and regulations. Reuse, reprocessing, resterilization, or repackaging of these single-use devices is prohibited and may compromise the structural integrity and/or sterility of the devices which may lead to device failure or patient infection.
Do not use in ischemic or necrotic tissue.