CDRH Launches ‘Health Of Women’ Program; Research Agenda To Focus On Ortho, Cardio Devices

The device center plans to develop a research roadmap to explore sex-based differences in outcomes to musculoskeletal and cardiovascular disease devices, as well as devices targeting diseases specific to women. CDRH launched the effort as part of its new “Health of Women” initiative at a June 24-25 workshop.

FDA’s Center for Devices and Radiological Health launched its “Health of Women” initiative to strengthen the focus of FDA, industry and the clinical community on developing more devices that are studied and designed to account for the unique clinical needs of women.

The program, unveiled at a June 24-25 workshop at FDA headquarters in Silver Spring, Md., will put emphasis on expanding device research and development efforts focused on women in three general clinical areas: musculoskeletal disease, cardiovascular diseases and diseases that specifically impact women, such as those in the obstetrics and gynecology space.

The HoW effort “encompasses health conditions that are specific to women; are more common or more serious in women; have distinct causes or manifestations in women; have different outcomes or treatment options in women; or have higher morbidity or mortality in women,” CDRH officials explained at the workshop.

CDRH says it wants to develop a priority research “road map” into women’s health issues and also address long-recognized gaps in recruitment and retention of women in device studies and in the collection of sex-specific findings from trials.

The center sought ideas from stakeholders at the gathering to develop research priorities to better define sex-specific differences in the targeted clinical categories.

Ultimately, CDRH, through the program, says it wants to develop a priority research “road map” into women’s health issues, and also address long-recognized gaps in recruitment and retention of women in device studies and in the collection and communication of sex-specific findings from device clinical trials.

CDRH has acknowledged previously that devices often move through the FDA review process based on data from trials that lack significant female participation and/or lack sex-specific data analysis. (See (Also see "Study Finds Heart Device Trials Male-Dominated; FDA Promises Guidance" - Medtech Insight, 7 Mar, 2011.).) In December 2011, the center issued a draft guidance on “Evaluation of Sex Differences in Medical Device Clinical Studies.” The guidance seeks to advise planners of pivotal device trials to incorporate a pre-specified plan for analyzing outcome differences among women and men, and where appropriate, to power trials to permit separate evaluations of device performance by sex. (See (Also see "Clinical Trial Guidance Seeks To Improve Sex-Based Data" - Medtech Insight, 2 Jan, 2012.).)

The draft guidance is “still under revision,” according to an FDA spokeswoman.

HoW is a broader-reaching effort to advance the exploration of how devices work differently in women than in men.

Focus On Musculoskeletal, Cardiovascular

The device center chose musculoskeletal diseases as one priority area because treatments of such conditions are impacted by the different anatomies of women and men. Researchers have identified clear sex-based differences in areas including hip implant failure rates, pain levels following knee replacement surgery, and outcomes from devices to treat wrist fragility fractures.

CDRH epidemiologist Lisa Torosyan, for example, presented a synopsis of research at the workshop drawing on data from the Kaiser Permanente Total Joint Replacement Registry, showing that women have higher revision rates for total hip arthroplasty failures. She also highlighted the statistics from a 2011 study showing that in metal-on-metal hip surgeries, there was a much higher incidence of aseptic loosening and a higher incidence of cup revisions in women over men, and that women experienced more than three times the failure rate for metal-bearing complications than men did.

In the cardiovascular space, recent analyses of large cardiovascular device trials have helped to start pinpointing why certain devices work differently in women.

Boston Scientific Corp.’s large MADIT-CRT trial, which paved the way for the use of cardiac resynchronization therapy (CRT) in a broader population of less-symptomatic heart failure patients, was highlighted at the workshop. (See (Also see "More Patients Should Receive Cardiac Resynchronization Therapy, Heart Groups Say" - Medtech Insight, 17 Sep, 2012.).) CDRH researchers were able to further “mine” results of this trial to come up with an explanation for why women appear to benefit so much more than men from CRT.

One obvious reason, explained Kim Selzman, a medical officer within CDRH’s Division of Cardiovascular Devices, is that researchers discovered that all patients who had a left bundle branch blocks, which is a defect in the heart's electrical impulses that causes asynchrony between left and right ventricle contractions, benefited more from CRT than those without that particular defect. (See (Also see "FDA Panel Endorses Expanded Approval For Boston Scientific CRT-Ds" - Medtech Insight, 22 Mar, 2010.).) And “women tended to have a greater proportion of left bundle branch blocks” as part of their morphology, she said, with 87% of women in the MADIT-CRT trial showing the feature, compared to 65% of men.

CDRH officials say they hope to use the HoW initiative to establish a research agenda that builds on these type of analyses. And, ultimately, they want to specify cross-cutting clinical themes, such as body weight issues and inflammatory response in women, which might explain sex-specific differences in treatment outcomes across clinical specialties.

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