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New vasectomy clip receives FDA approval
The Food and Drug Administration (FDA) has approved a new device to be used in vasectomy procedures: the Vasclip, a small polymeric clip designed to stop the flow of sperm through the vas deferens.
The Vasclip Co. of Roseville, MN, which manufactures and markets the device, has begun to sell the Vasclip to physicians in select major markets throughout the United States and expects to expand its national availability in the next several months. The company is marketing the device as a less invasive alternative to traditional vasectomy because it claims it eliminates cutting, suturing, and cauterizing of the vas deferens.
No clinical research on the Vasclip has been published in peer-reviewed journals, according to Scott Olson, director of the company’s public relations and marketing communication. However, results of the device’s clinical study are being drafted for peer-reviewed clinical journal submission during the third quarter of 2003. A paper comparing the socioeconomic benefits of the Vasclip vs. alternative birth control options also is being readied for publication in the same time frame, reports Olson. (Contraceptive Technology Update will report on the results of the research upon publication.)
With more clinicians moving to evidence-based practice, which relies on identifying and reviewing relevant scientific literature to determine the value of a diagnosis, treatment, or test, availability of peer-reviewed data is necessary in considering any new procedure. Until the Vasclip data are published in peer-reviewed journals, any claims about the device’s safety or efficacy are subject to question, observes Amy Pollack, MD, MPH, president of the New York City-based EngenderHealth. EngenderHealth, formerly AVSC International, provides information on male and female sterilization as part of its global reproductive health focus.
Examine the results
The company offers results of the clinical study in its promotional literature. That material states that 124 men were enrolled in a prospective, clinical study, in which the complication rate and pain associated with the Vasclip were lower than traditional vasectomy techniques, based on a review of 26 other peer-reviewed reports.
According to the data supplied by the company, less than 1% of the subjects (one of 124) had clinically significant swelling (hematoma); one of the 124 men reported a sperm granuloma. None of the men in the study reported an infection. A total of 116 out of 119 men became azoospermic (clinically infertile) at or after 90 days post-procedure. Three men did not become infertile due to improper placement of the device. Five men were lost to follow-up before the 90-day exam and semen analysis.
In an extension of the study, which included 68 men, 100% tested as infertile at an average of 372 days post-procedure. In a post-study survey, which included responses from 110 of the 124 men, 99% indicated they would recommend the Vasclip procedure to others.
Review the procedure
According to the company, the Vasclip procedure does not require providers to change or modify their preferred methods for scrotal access or closure during the vasectomy procedure. Using commonly practiced vas deferens palpitation and scrotal access techniques, the Vasclip procedure reduces the vasal sheath manipulation necessary to access the vas deferens.
The vas deferens is exposed through the vasal sheath by effacement of the clear side of the sheath, eliminating cutting or management of the mesenteric bundle. By locking Vasclip around the exposed vas deferens, cutting, suturing, and cauterizing of the vas deferens is eliminated, states the company literature.
"I think that a traditional vasectomy is a fairly straightforward and quick procedure," observes Robert Brannigan, MD, assistant professor in the department of urology, Northwestern University Medical School, and head of the division of male reproductive medicine and surgery at Northwestern Memorial Hospital, both in Chicago. "I would say that this definitely takes even less time, and it’s certainly more straightforward in that there is no use of cautery and no use of any instruments to divide the vas deferens and tie it off with suture."
Brannigan spoke with Contraceptive Technology Update after performing his first Vasclip procedure. Scrotal access and isolation of the vas deferens was the same, says Brannigan, who has performed traditional vasectomies for five years.
"There’s something called the vasal sheath which is opened up to isolate the vas deferens itself, and what’s different about it is that rather than dividing the vas deferens and tying each end off with suture, the Vasclip device is simply applied across the vas deferens," Brannigan comments. "I would say, with the experience I’ve had so far, there does seem to be a little bit less manipulation of the vas deferens."
Brannigan prepared for the procedure by reading the physician training manual, reviewing the companion CD-ROM, and using the training kit, which enabled him to practice the procedure by placing the clip on silicone tubing consistent in diameter to a vas deferens. The company also offers the option of having a clinical advisor visit the physician’s site to provide counsel and instruction during initial Vasclip procedures.
The device cost is $350; the procedure is a separate charge. According to the New York City-based Planned Parenthood Federation of America, vasectomy fees range between $240-$1,000 for an interview, counseling, examination, operation, and follow-up sperm count; some clinics and doctors use a sliding scale according to income.1 For the Vasclip procedure, physicians are expected to use one of two CPT-4 procedural reimbursement codes and receive the same reimbursement amount that they currently receive for vasectomy, says Olson. Some payers may not cover reimbursement for the Vasclip device cost; however, the company believes payers will begin to issue coverage, says Olson.
"We have prepared a reimbursement guidelines book for the physician’s office, which provides suggestions and samples for proper coding, pre-authorizations, letter of medical necessity and denial appeals," reports Olson. "We have hired a reimbursement consultant to assist us in educating payers on the benefits of the Vasclip procedure vs. traditional vasectomy."
For more information on the Vasclip, contact: Customer Service, 3030 Centre Point Drive, Suite 900, Roseville, MN 55113. Telephone: (866) 827-2547 or (651) 631-1830. Fax: (651) 631-1850. E-mail: email@example.com. Web: www.vasclip.com.
1. Planned Parenthood Federation of America. All About Vasectomy. Accessed at: www.plannedparenthood.org/BIRTH-CONTROL/allaboutvas.htm.