New ‘See-and-Treat’ Tissue Resection System Cleared to Sell in the U.S.

Distal Access has completed U.S. Food and Drug Administration registration for the Resectr 9 Frenc/3 mm high-performance disposable tissue resector. The move allows the company to begin selling the product in the United States.

Soft tissue resection is performed throughout the body. The procedure typically involves inserting a small metal cannula with rotating internal cutting blades up against tissue then actuating the cutting blades with an electromechanical motor to cut and aspirate tissue. Physicians typically give up “feel” and “control” when using electromechanical systems.

“Patient safety always comes first. So, we innovated a non-powered and hand-held manual surgical instrument controlled by the physician’s hand,” said Chris Livingstone, vice president of sales and marketing for Distal Access. “Clinicians can increase or decrease tissue resection speed and aspiration based on what they see and feel during the procedure.”

Electromechancial systems are expensive. These systems require the hospital, clinic, or office to buy complex and expensive capital equipment then pay $500 to more than $1,000 per patient for single-patient-use disposables. Many clinics and offices can’t afford electromechanical capital equipment or disposables.

“Electromechanical systems are complex and expensive with limited availability outside of hospitals,” continued Livingstone. “The Resectr high-performance disposable tissue resector shows up ‘ready-to-use’ at the hospital, clinic, or office. Complex expensive capital equipment is not needed and the disposables cost less than other systems.”

Certain tissue resection systems are used as accessories to hysteroscopes during uterine polyp removal. Clinicians surveyed at the American Congress of Obstetricians and Gynecologists and European Society for Gynaecological Endoscopy expressed a strong need for a system that allows clinicians to “see-and-treat” lesions in one setting to improve patient comfort and care.

“Many patients are lost in follow up between office diagnosis and hospital treatment. Those patients live with pain and other complications,” added Livingstone. “The Resectr platform gives clinicians an important tool to ‘see-and-treat’ lesions in a variety of clinical settings where it is best for the patient’s care.”

According to the company, the Resectr technology may allow patients to be treated earlier, many in the office, to alleviate pain and remove lesions before they are allowed to grow.

The Resectr is manufactured by Distal Access, a Salt Lake City, Utah-based company that develops various medical devices including guidewire controllers, catheter controllers, medical device controllers, thrombus macerators, catheter cleaners and distal access catheters. Its Resectr technology is protected by 12 issued and pending patents.