In the past, I have written about how studies on devices and drugs seem to lack focus on women, for several reasons. Reasons range from a poor understanding of the differences in male and female anatomy and physiology, poor access to healthcare, lack of awareness and efforts to enroll women, and lesser demands for evidence from journals, insurers and other healthcare stakeholders. I previously posted about Boston Scientific’s efforts to enroll more women, and now, here is another positive study from Endologix.
Enrolling women, or studying the effects of devices, procedures and therapies exclusively in women go further than improving medical knowledge, when successful, they can also make for sound business sense, regardless of the risks and expenditure.
AAA – Abdominal Aortic Aneurysms
The aorta is the main artery that supplies blood to most of the body, and in the abdominal region, it splits into two arteries that supply blood to the pelvis and legs. Due to smoking, high blood pressure and/or other risk factors, the aorta can come under pressure and enlarge, and eventually burst, which can cause hemorrhage and death, if not operated on immediately. Aneurysm also presents with a lot of pain, and the risk of rupture when the aneurysm reaches a certain size, requires surgical correction and grafting/stenting.
Open Vs. Minimally Invasive Repair
There are two ways an abdominal aortic aneurysm is surgically treated – open surgery and minimally invasive repair through a groin incision. Both surgeries have approximately the same effectiveness, but open surgeries can take a long time to recovery, while minimal surgeries requires numerous post-surgical visits to ensure no leaks or other morbidity is present. However, eligibility for surgery varies.
Learn more about Endovascular Aneurysm Repair (EVAR)from this brief video (note that Cook Medical provided a grant towards the video):
The Endologix Lucy Trial
Endologix, which has developed a stent for AAA treatment, enrolled 225 patients, 149 male and 76 female. They claim that, with their stent, termed the Ovation® Abdominal Stent Graft System, increased eligibility for women by 28%.
Besides claims that the device reduces mortality and is better suited for women, the study is also the first to study the effects of the device and surgery on women. Women are at a lower risk for AAA, but the outcomes are worse for women treated through EVAR or through open surgery. I found a study that confounded this outcome difference, however, the study was not specifically well designed to study gender differences. However, it is clear that anatomical differences remain, and thus drive the variability in outcomes, and this is potentially why the Endologix device claim makes sense.
The results Endologix has presented, are of course, initial results based on the 30-day follow up period common for EVAR, and observations over long term will yield more confidence in the device’s ability to treat women better.
However, as I mentioned earlier, it makes for good clinical sense and business sense to enroll more women in clinical trials, and the Lucy trial is one more step in the right direction!
- The MASS Device Article: http://www.massdevice.com/endologix-touts-30-day-data-study-ovation-stent-graft-women/
- A Business Wire write-up by Endologix: http://www.businesswire.com/news/home/20170531006467/en/Endologix-Reports-Positive-Clinical-Data-Ovation-LUCY
- A large, open-access study on gender based outcomes: http://www.jvascsurg.org/article/S0741-5214(12)02188-X/fulltext
- A Mayo Clinic Overview of AAA: http://www.mayoclinic.org/diseases-conditions/abdominal-aortic-aneurysm/home/ovc-20197858
- Society for Vascular Surgery on AAA Repair: https://vascular.org/patient-resources/vascular-treatments/endovascular-repair-abdominal-aortic-aneurysms#whyitsdone
- Image courtesy, Pexels: https://www.pexels.com/photo/woman-water-girl-lake-134670/