Two independent clinical studies show that Cook Medical's BIGopsy® Backloading Biopsy Forceps' ability to obtain larger tissue samples for biopsy can lead to an improved ability to diagnose the cause of suspicious ureteral or kidney lesions. The results of both studies were presented separately at the 2010 American Urological Association (AUA) Annual Meeting in San Francisco.

BIGopsy's unique design allows for removal of tissue specimens up to 4 mm3 in size, which is four times the size of samples taken with other forceps on the market. BIGopsy's larger sample can lead to first-time diagnosis negating the need for repeated procedures that result from an inadequate tissue sample.

One study, conducted by Shaun Wason, Alan Schned, John Seigne and Vernon Pais Jr. at Dartmouth Medical School, compared the diagnoses resulting from tissue samples taken with the BIGopsy forceps versus the market-leading forceps.

Researchers used ex vivo nephroureterectomy specimens to obtain tissue samples for biopsy. The BIGopsy samples were significantly larger than those obtained with the other biopsy forceps (average sample size of 31.2 +/- 34.6 mm2 vs 3.5 +/- 2.8 mm2). Unlike the competitor device, the BIGopsy specimens were accurately identified in all pathology reports.

The market's leading biopsy forceps were used to obtain a total of six biopsy samples from three different specimens. The samples ranged in size from 1 to 8 mm2 with an average size sample size of 3.5 +/- 2.8 mm2. Using the same three specimens, BIGopsy was used to obtain five samples with sizes ranging from 6 to 80 mm2 with an average sample size of 31.2 +/- to 34.6 mm2, resulting in an average size that was about nine times larger than market leading biopsy forceps.

In all three cases, the test results derived from BIGopsy agreed with the final pathological report. Unlike BIGopsy, samples from the other biopsy device agreed in two cases but disagreed in the third. The smaller sample resulted in the tissue being misassigned as malignant.

In addition to their pathological conclusions, the researchers found the BIGopsy tissue specimens were less distorted and fragmented, making them easier for pathologists to interpret. The researchers concluded that improved biopsy quality may translate into improved ability to diagnose ureteral and renal pelvic mucosa lesions endoscopically.1

A second study2 presented at AUA by Saeed Al-Qahtani, Dorian Legraverand, Sixtina Gil-Diez de Medina, Malthilde Sibony and Prof. Olivier Traxer conducted at the Hôpitol Tenon in Paris, France, also compares the biopsy sample quality of the BIGopsy biopsy forceps to the market leader for upper-tract urothelial tumors. A total of 14 patients were biopsied using both types of forceps and a single pathologist then analyzed the blinded samples.

The histopathology results of the biopsies performed with BIGopsy were of equal or better quality than biopsies performed with the other brand of biopsy forceps.

In their conclusions, the researchers noted that their study demonstrates the advantage of BIGopsy and strongly recommended it for the evaluation of upper urinary tract transitional cell carcinoma (UTT-TCC), especially in the case of conservative treatment.

"The BIGopsy forceps provide surgeons and pathologists with a tool for retrieving the largest, biopsy samples which may lead to more accurate diagnosis," said, global leader for Cook Urology. "These studies help to determine the best course of treatment for the patient without needing a second biopsy. We're pleased with these results and are eager to continue delivering the highest quality medical devices to help drive better patient care and improve the procedural needs of today's physicians."

1. Wason S, Schned A, Seigne J, et al. Evaluation of adequacy of pathological specimens using a novel backloading ureterscopic biopsy forceps. J Urol 2010;193(4)(Suppl.):e354-e355.

2. Al-Qahtani S, Legraverand D, Gil-Diez de Medina S, et al. Could we improve the biopsy quality of the upper urinary tract transitional carcinoma (UTT-TCC)? (Evaluation of a new biopsy forceps). J Urol 2010;183(4)(Suppl.):e497.

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