REDWOOD CITY, Calif.,
April 26, 2018 /PRNewswire/ --
Minerva Surgical has filed a formal written complaint, and a
request for immediate retraction, with Dove Medical Press,
regarding a recent publication in their International Journal of
Women's Health, or the IJWH, titled: Efficacy
and patient satisfaction after NovaSure and Minerva endometrial
ablation for treating abnormal uterine bleeding: a retrospective
comparative study. Hologic, the study sponsor, and the
Food and Drug Administration's (FDA) Center for Devices and
Radiological Health, Office of Compliance, were also notified with
a copy of the complaint.
The allegedly material misleading statements that violate the
Committee of Publication Ethics (COPE) guidelines, which the
IJWH states it follows during the peer review process,
appear in the Study Criteria section of the publication as
follows:
"We assumed that there would be fewer Minerva
vs. NovaSure subjects in general across study sites because
of its relatively new introduction. Therefore, at each study
site we enrolled all Minerva
subjects and an equivalent number of
NovaSure subjects."
Minerva believes the statement that "all Minerva
subjects" were enrolled is inaccurate, as only 92 Minerva
patients were surveyed as part of the study, while Minerva has
evidence that 256 patients were treated with the Minerva device at
the four clinical sites during the study period, including 169
patients at the lead author's clinical site alone. Also
troubling is Minerva's understanding, as supported by one of the
study site investigator's, that Hologic personnel were on-site, and
conducted the patient selection process. The same Hologic
personnel had access to the patient charts (electronic medical
records) at the clinics, and selected which Minerva patients and
which NovaSure patients were enrolled in the study. This obviously
biased patient selection process is not fully disclosed in the
paper.
A second materially misleading statement is:
"No subject's post-procedure bleeding
status was reviewed, queried, nor known at
enrollment, in either study arm."
This statement is suspect, as Minerva has obtained and provided
to Dove Medical Press, Hologic and FDA, a copy of an earlier study
manuscript draft that included the post-procedure bleeding status
analysis. This manuscript draft was submitted to, and
rejected by, the well-respected Journal of Minimally Invasive
Gynecology and the Journal of Gynecologic Surgery. This
analysis indicates that at the time of the early post-operative
visit, that on average occurred 59 days after treatment, patients
selected by Hologic for study participation exhibited the following
early outcomes:
- NovaSure patients had a 31% higher Amenorrhea rate (zero
bleeding) vs. Minerva.
- NovaSure patients had a 27% higher Success rate vs. Minerva.
- NovaSure patients had a 0% failure rate due to heavy bleeding
vs. 8% for Minerva.
Because early post-procedure bleeding status is a strong
indicator of longer term efficacy, this analysis was reportedly a
reason for rejection of the manuscripts. Equally troubling is the
fact that this analysis was subsequently deleted from the
manuscript submitted to the IJWH and replaced with the above
statement.
Hologic's access to the patient's early post-procedure bleeding
status, when combined with the study sponsor's full control over
the patient selection process, data collection, and analysis,
resulted in a study population that was clearly biased in favor of
the NovaSure arm of the study.
Minerva believes that failure to disclose the actual methodology
of a study constitutes a clear violation of the COPE guidelines,
hides potentially significant selection bias, and distorts any
study conclusions.
According to David Clapper,
President and CEO of Minerva:
"We trust that Hologic will live up to its
Code of Ethics published on their website that commits them to
ethical conduct, to honesty, and to being truthful and upfront with
customers and shareholders. We also trust that the
International Journal of Women's Health will live up to its
commitment to abide by the COPE guidelines. Minerva looks
forward to the timely announcement that the Int'l Journal of
Women's Health has retracted this publication."
Minerva and NovaSure Pivotal Study
Information: The pivotal studies supporting FDA
approvals of the Minerva system (7/28/15) and NovaSure system
(9/28/01) were separate, randomized, prospective, multi-center
clinical studies, in which the Minerva and NovaSure systems were
compared to a control arm of wire loop resection plus rollerball
endometrial ablation (hysteroscopic endometrial ablation). The
Minerva study arm reported 1-year success rates of 93% and 1-year
amenorrhea rates of 72%, while the NovaSure study arm reported
1-year success rates of 77.7% and 1-year amenorrhea rates of
36%.
For more information on the Minerva procedure and full product
labeling, visit www.MinervaSurgical.com
About Minerva Surgical: Minerva Surgical is
an innovative medical technology company focused on improving
women's health by developing treatments for excessive menstrual
bleeding. Minerva and Minerva ES, and associated logos are
trademarks and/or registered trademarks of Minerva Surgical in
the United States and/or other
countries. All other trademarks, registered trademarks, and product
names are the property of their respective owners.
Important Safety Information: Minerva endometrial
ablation is for premenopausal women with heavy periods due to
benign causes who are finished childbearing. Pregnancy following
the Minerva procedure can be dangerous. The Minerva procedure is
not for those who have or suspect uterine cancer; have an active
genital, urinary or pelvic infection; or an IUD. Minerva
endometrial ablation is not a sterilization procedure. Rare but
serious risks include, but are not limited to, thermal injury,
perforation and infection. Temporary side effects may include
cramping, nausea, vomiting, discharge and spotting. For
detailed benefit and risk information, please consult the IFU.
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SOURCE Minerva Surgical