Rex Medical Completes Patient Enrollment for the REVEAL Peripheral Atherectomy U.S. Trial

March 19, 2019 Off By BusinessWire

CONSHOHOCKEN, Pa.–(BUSINESS WIRE)–Rex
Medical, L.P., a medical device design and development company,
today announced the successful completion of enrollment in the
Revolution™ Peripheral Atherectomy System for Lower Extremity Peripheral
Arterial Revascularization (REVEAL) IDE clinical trial. The REVEAL trial
is a single arm, prospective study to evaluate the safety and
effectiveness of the Revolution™ Peripheral Atherectomy System in the
treatment of infrainguinal lower extremity peripheral arterial occlusive
disease. 121 patients were successfully enrolled in 17 U.S. sites. The
company will file a regulatory submission to the U.S. Food and Drug
Administration (FDA) in May, 2019 and is currently under CE review.

Peripheral artery disease (PAD) and its most severe form, critical limb
ischemia (CLI), affect over 10 million people in the U.S. and occur when
an artery becomes blocked or narrowed due to plaque or calcium deposits
which in turn reduces blood flow to the lower extremities. Left
untreated, this can result in pain, ulceration, gangrene and amputation.
Successful revascularization and blood flow restoration is essential in
the treatment and quality of life improvement for this patient
population.

The Rex Medical Revolution™ Peripheral Atherectomy System is an
innovative and ergonomically designed low profile rotational atherectomy
system (140,000 RPM) with continuous mechanical aspiration for
below-the-knee (BTK) and above-the-knee (ATK) applications including
multiple plaque morphologies ranging from thrombus and soft plaque to
severely calcified lesions. This device is operated by a 72 watt power
supply similar in size to a laptop computer charger and requires no
capital equipment along with minimal setup time prior to use.

Jeffrey G. Carr, MD, FACC, FSCAI, Cardiovascular Associates of East
Texas, served as the study’s Principal Investigator and stated, “In our
experience, the Revolution technology demonstrated effective vessel
preparation in a diverse set of lesions both above and below the knee
prior to adjunctive therapy. In addition, the efficient aspiration
feature reduces the potential for intraprocedural embolization and
associated complications. No capital equipment along with fast and
user-friendly set up is a discernible advantage to those physicians
performing procedures in office interventional suites (OIS), outpatient
surgery centers (ASCs) and hospital settings.”

Commenting on the recent regulatory achievement, Rex Medical President,
Lindsay L. Carter, “The successful completion of this trial is an
important milestone for our company. We would like to thank all site
investigators and clinical teams for their support and hard work
throughout this study and look forward to working with both U.S. and OUS
regulatory agencies to bring this differentiated technology to the
interventional community and patient population undergoing treatment for
peripheral arterial disease.”

Rex Medical, L.P., based in Conshohocken, PA., is a privately held
medical device company specializing in the development, manufacturing
and marketing of minimally invasive medical devices targeted towards the
cardiovascular, venous access, endosurgery and oncology markets. Rex
Medical is ISO 13485 certified.