Clinical investigators complete record enrollment
in real-world Registry, HEAL (An All-comers Registry of the
MicroStent PeripHeral Vascular StEnt in subjects with PeripherAl
ArteriaL Disease)
WILMINGTON, Mass., June 18,
2024 /CNW/ -- Micro Medical Solutions
-- Micro Medical Solutions, a leader in providing innovative
medical device solutions, is excited to announce that it has
achieved a major milestone with the enrollment of its 200th patient
in the HEAL Registry. This unique registry is focused on gathering
real world evidence using its MicroStent technology for treatment
of patients with Chronic Limb-Threatening Ischemia (CLTI) and
Critical Limb Ischemia (CLI).
CLTI and CLI are debilitating conditions that affect the blood
vessels in the legs and feet. Those afflicted with this disease
often suffer from severe pain, numbness, and open non-healing
wounds. Without intervention, these conditions can lead to
amputation, loss of mobility, and death. Micro Medical Solutions is
committed to providing a potential solution for this medically
complex and underserved patient population.
The HEAL Registry, enrolling patients at ten sites in EU
countries, including Italy,
Germany, Belgium, Austria and the
Netherlands, is crucial clinical research in evaluating the
use of MMS' MicroStent to treat real world patients afflicted with
CLI/CLTI. HEAL's research endpoints provide real world evidence of
the effectiveness and safety of treatment with the
Micro Stent. With enrollment of 200 patients, the registry has
reached a significant clinical and research milestone. The registry
is also collecting specific data outcomes in below-the-ankle
treatment, specific to wound healing. This data will be reported
alongside MMS' US IDE study data to the FDA in its premarket
approval application (PMA).
"We are proud to have created the largest real-world cohort of
patients and data collection for an implanted stent below the knee
in the HEAL Registry," said Greg
Sullivan, CEO of Micro Medical Solutions. "This milestone is
a testament to our commitment to providing innovative solutions for
those suffering from CLI/CLTI. We are optimistic about the
encouraging data that has emerged from the registry and look
forward to utilizing this information to continue providing
effective treatment options."
Micro Medical Solutions completed enrollment in its STAND IDE
study, a Randomized Controlled Trial, in the US in December of
2023. MMS expects to share this data in early 2025. STAND reflects
controlled patient selection with required follow up visits, HEAL
reflects general CLI/CLTI patient population treated in everyday
practice while including required follow-up. The combination
of RCT and RWE data will provide physicians with the
opportunity and confidence to make treatment decisions using
evidence-based medicine.
MMS is dedicated to making a positive impact on the lives of
those affected by this limb threatening disease and is committed to
using real world data to support its mission to support physicians
in their management of these patients.
Thank you to the physicians and patients for their continued
support as we strive towards providing effective and innovative
solutions for those in need.
About Micro Medical Solutions
For more about Micro Medical Solutions, visit
www.micromedicalsolutions.net.
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SOURCE Micro Medical Solutions