Medical Device Daily

Cook (Bloomington, Indiana) on Monday officially launched its Women's Health business unit at the American College of Obstetrics and Gynecology (ACOG; Washington) annual clinical meeting that began Saturday and continues through tomorrow in the nation's capitol.

Cook's Women's Health, drawing on 40 years of experience at Cook, will work to address “some of the most prevalent issues” in women's health including infertility, chronic pelvic pain, pelvic organ prolapse and incontinence.

“Knowing that, we have actually lined out a roadmap throughout the different life stages of a female patient, basically starting [with] teens, then the group of 20 to 40, 40 to 60 and 60-plus,” Christina Anné, strategic business unit leader of Cook's Women's Health, told Medical Device Daily.

In completing “extensive research and surveys,” Cook said that it found that women are “confronted” with the potential for a host of diseases throughout their lifetimes.

“That is one aspect that gave us, actually, the drive to start a women's health business unit,” Anné said.

Up until now, one big area of focus for Cook has been in vitro fertilization, but she said that the company wanted to go beyond that, to “look at a female in the whole.”

Another driver for Cook is the recognition that even besides the obvious differences between men and women, men and women's bodies are different in a wide range of less obvious ways and therefore require different devices and treatments, sometimes for the same diseases.

Anné said that “because of the knowledge gap in medicine, women have not always gotten the proper treatment, because women have always been excluded in randomized studies because of their fertile age.”

Therefore, in studies for pharmaceuticals, devices or other healthcare products, the decisions on those items are made on an “average population that is mainly male,” she said.

Cook is seeking to change that approach.

“Cook can do that pretty [easily], because we have the technology and innovation in our other business units . . [including] business units on cardiovascular diseases, endoscopy or surgery, so we have internal knowledge within our company, and it's been pretty easy for us to do cross-fertilization . . . to bring those technologies and actually adapt [them] to the female patient,” said Anné.

One example of a product being developed by the unit that addresses both genders but has to be tailored for the female body is a device for abdominal aortic aneurysm.

“Obviously, those sizes [of AAAs] are very different for women than the sizes for men,” she said.

Cook's Women's Health going forward will be working on products to “maintain quality of life during pelvic organ surgery” to be introduced this summer, Anné said.

“There are a couple of products [on the market] today, but they are synthetics, and we try to stay away from synthetics because [they] are known as a foreign body,” she said.

One of the products is based on technology that Cook owns and worked on with the University of West Lafayette (Indiana), she said, that being small intestinal submucosa (SIS) technology. Cook describes SIS as an “acellular biomaterial that supports soft tissue repair with a scaffold-like matrix having an all natural structure and composition. The company said that devices with SIS “remodel into organized tissue.”

It can be used to help restore the elasticity to tissues – something that decreases with child-bearing and age – and help the patient maintain quality of life after pelvic organ surgery, she said.

To form the Women's Health unit, Anné said that Cook relied not only on existing technology but also drew on personnel already employed by the company. The number of people the Women's Health unit has now nearly doubled, she said.

Currently, the unit has about 100 people dedicated to it globally, and it will be a “continuous process” of adding more people at all levels around the world.

While developing a broad focus on the various specific health needs of women vs. men, the company said it is continuing to pursue those women-only offerings, adding more advanced features and new technologies.

It is taking its in vitro fertilization (IVF) technology and adding “new packages” to existing packages and continuing to evolve the technology. These products are expected to be available this summer.

Among the products in the “silo of the IVF” are innovations in culture media and a full line of products for in vitro maturation, Anné said.

Also scheduled for introduction this summer are new products for the labor and delivery for high-risk obstetric patients.

In other news from the meeting:

• Conceptus (Washington), developer of the Essure non-incisional permanent birth control system, reported that a study being presented at the ACOG meeting suggests tissue will gradually encapsulate the coils of the Essure micro-insert that trail into the uterine cavity following hysteroscopic sterilization.

A second study suggests the Essure procedure can be performed on women suffering from serious health conditions with a high margin of safety eliminating the risk of complications that commonly follow laparoscopic tubal ligation carried out under general anesthesia.

• ACOG, citing frustration with regulatory roadblocks of the Plan B “morning-after pill,” unveiled its “Ask Me” campaign, which encourages patients to obtain an advance prescription from their ob/gyn.

Representing more than 49,000 U.S. obstetricians and gynecologists, ACOG has long advocated for national over-the-counter access to Plan B, and has accused the FDA of stalling to approve over-the-counter use for political reasons.

Vivian Dickerson, MD, the college's past president, said, “This is really a call to action – a call to make Plan B available and to make sure patients know how to use it.

“This is a call to physicians to educate their patients and to discuss this with their patients. This is a call to patients that this is something available, that this is an option available. Most importantly, this is a call to the FDA so they can make a decision.”

Nine states currently allow women to obtain Plan B without a prescription. Women in other states have to make a doctor's appointment to get the prescription, which can be a problem for those whose doctors are not readily available.