New device alleviates pain and trauma of traditional vasectomies.

In what may be “the most significant advancement in vasectomies since World War II,” a Roseville, Minn., company has developed a device that permanently blocks the flow of sperm without cutting or cauterizing the vas deferens, thus reducing the pain and complication rate associated with traditional vasectomies. In traditional vasectomies, surgeons cut open the scrotum, sever the vasdeferens, remove a piece of the tubes, and cauterize them, a procedure that can lead to infections in thevas deferens and results in significant pain for many patients, according to some studies. In an effort to reduce the discomfort—and men’s “trepidation” toward the procedure—VMBC has developed the Vasclip, “a plastic clamp the size of a grain of rice” that attaches to each of the two vas deferens tubes to permanently block the flow of sperm. The device can be attached in 10 minutes during a physician office visit, and VMBC expects insurers will cover the device’s $385 cost. Recovery time from the outpatient procedure is minimal, and VMBC says that in a year-long clinical trial, 76% of men receiving the Vasclip indicated they felt “no pain at all” or “less [pain] than expected,” and 99% said they were satisfied with the procedure and would recommend it to their friends. About 5% of participants indicated that they experienced “significant pain” with the Vasclip, compared with up to 54% of patients undergoing traditional vasectomy, according to some studies. In addition, for men who change their minds, the Vasclip procedure may be easier to reverse than traditional vasectomy, according to the Los Angeles Times. Physicians hope that Vasclip, which received FDA approval last August and recently went on the market, will make sterilization a more attractive option for men, saving some women from the “far more complicated and expensive tubal ligation procedure.”

VASCLIP, THE ALTERNATIVE TO VASECTOMY, RECEIVES FDA CLEARANCE

The VASCLIP Company announces it has received FDA clearance to commercialize the VASCLIP device and will immediately begin to market it as a new, less invasive alternative to vasectomy.

The VASCLIP is a small polymeric clip about the size of a grain of rice that atraumatically locks around the vas deferens, which stops the flow of sperm through the vessel. The biocompatible VASCLIP is a less invasive alternative to traditional vasectomy because it eliminates all cutting, suturing and cauterizing (burning) of the vas deferens.

In a clinical study, the patented Vasclip was shown to significantly reduce the incidence of painful and costly complications when compared to published vasectomy studies. The Vasclip clinical study indicated high patient satisfaction. The Company has begun to sell the VASCLIP to physicians in select major markets throughout the United States, and expects to expand its availability nationally over the next several months.

More than 4 million vasectomy procedures are performed annually on a worldwide basis, with more than 500,000 performed each year in the United States. It is reported that more than 15,000 physicians perform vasectomies in the United States, with urologists performing about 70 percent of all procedures and family practice physicians and general surgeons performing the rest. Between 4 and 6 percent of men who undergo a vasectomy seek to have it reversed. By eliminating the need to cut and cauterize the vas deferens, the Company believes the VASCLIP will facilitate reversal of the procedure and intends to conduct a future clinical study exploring that possibility.

In the VASCLIP 124-patient clinical study, less than 1 percent of the subjects (1 of 124) had clinically significant swelling (hematoma), compared with the reported 0.1 to 15.0 percent of men that have a hematoma after undergoing a traditional vasectomy. Additionally, no subjects (0 of 124) in the study reported an infection -- a marked decrease from the reported 0.2 to 6.9 percent from traditional vasectomy. The VASCLIP procedure was also found to significantly reduce-sperm granuloma (2 of 124), which affects between 15 and 40 percent of all patients that have a traditional vasectomy. Ninety-nine percent (109 of 110) of the subjects that responded to a post-study survey indicated they would recommend the VASCLIP procedure to other men.

In addition to the clinical and cost benefits that the VASCLIP provides as “The Alternative to Vasectomy,” the VASCLIP procedure offers men and women a new birth control option. “With the availability of the VASCLIP, the time has arrived for men to accept more responsibility for family planning,” said David Elliot, President and CEO of The Vasclip Company. “Women still bear the burden for birth control over 80 percent of the time. For many women, hormone based contraceptives are not optimal and any form of tubal ligation carries unacceptable risks. Based on our research we believe the VASCLIP alternative to vasectomy is long overdue, and will be welcomed by women, men and their doctors.”

Men cite the fear of pain and complications as the primary reason they will not have a vasectomy. “I backed out of two vasectomies because of the reported complications and pain associated with traditional vasectomy. My concerns served as a great motivator in developing this product,” said company Founder and Chairman, Jim Segermark. “As the first person to ever have the VASCLIP procedure, I have personally experienced the benefits. Very simply, for men and couples that are seeking a solution for family planning, the VASCLIP procedure is an option that has benefits for both partners.”

“The VASCLIP device is simple to use,” said Dr. David Kirby, a clinical investigator in the VASCLIP study. “Unlike many new procedures, the VASCLIP procedure is office-based and does not require extensive training. A physician can use the same access and closure technique they have always used, but will not need to cut, suture or cauterize the vas deferens or manage vasal sheath damage. The dramatic reduction of complications associated with the VASCLIP procedure benefits the patient, physician and payor.” Dr. Kirby added, “I believe that for these reasons the physician community, urologists and family practice physicians alike will rapidly adopt the VASCLIP as the standard of care.”

VMBC, LLC, The VASCLIP Company, is privately held and is headquartered in Roseville, Minn. For more information about the Company and the VASCLIP, please visit the Company Web site at www.vasclip.com.