Reproductive Health device company Rinovum Women’s Health, Inc., has received CE mark approval for The Stork®. The Stork is a take-home conception aid designed to assist couples with becoming pregnant from the privacy of home.
Background
Rinovum Women’s Health, Inc. says dedicates itself to bringing products into the market that will enhance women’s lives and empower them to take charge of their health. That seemingly extends to devices designed to increase the odds of getting pregnant, and what better name for such a gizmo than The Stork. This is described as a drug-free product that uses a condom-like sheath for collection and a tampon-like applicator for delivery of semen to the cervical opening by way of cervical cap. As such it is an easy way to “bridge the gap” between natural intercourse and more aggressive assisted reproductive treatments.
The Stork is indicated for home use assisted insemination by couples who are trying to become pregnant. The Stork contains a cervical cap inside a condom-like silicone sheath and an applicator. It is used to collect semen into a cervical cap then deliver it to the outside of the cervix as an aid to conception. The Stork cervical cap is left in place for up to 6 hours before being removed. What happens then is entirely in the lap of the Gods, and Rinovum helpfully provides a bunch of quotes from references suggesting that its device, or at least the concept, works.
Company comments
“Our recent achievement of the CE mark for The Stork is a significant milestone for Rinovum. The Stork can now reach couples trying to conceive in both the EU and Canada. The great news is that The Stork will be available to them without a prescription from a physician. As couples attempt to nudge the stork with ovulation predictor kits, they can now go beyond simple diagnostic support, and get one step close to their goals of building a family naturally,” says CEO and founder, Stephen Bollinger.
We say
Having reviewed the company’s website and some of the papers cited in support of this concept, we’re unsure whether to welcome the device as another means by which those struggling for a baby could improve their odds, or whether the evidence is perhaps a bit too thin to support the claims. They’re not exactly burying us under the weight of prospective randomised studies, but who knows.
Source: Rinovum Women’s Health, Inc., Business Wire
published: August 22, 2013 in: Approval/Clearance, Clinical Studies/Trials, Gynaecology/Obstetrics