Paragon 28®, Inc. Receives FDA Approval for IDE Feasibility Study of Its SMART Total Talus™ System for use in Conjunction with the APEX 3D™ Total Ankle Replacement System
11 Septiembre 2023 - 6:00AM
Business Wire
Paragon 28, Inc. (NYSE: FNA), announced today they have received
an Investigational Device Exemption (IDE) approval from the FDA to
commence a feasibility study for configurations of the SMART Total
Talus™ System used in conjunction with the Paragon 28® APEX 3D™
Total Ankle Replacement System. The study is expected to begin in
early 2024.
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Paragon 28’s first in the world
3D-printed Patient Specific Talus Spacer. Use in treatment of
avascular necrosis (AVN). FDA approval: February 17, 2021 through
an approval order for a Humanitarian Device Exception (“HDE”).
(Graphic: Business Wire)
This milestone is an important achievement in the advancement of
Paragon 28’s SMART 28℠ strategy, which targets to provide
meaningful options to their surgeon customers and significantly
improve patient outcomes. The IDE of the SMART Total Talus adds to
the company’s existing Patient Specific Total Talus offering by
expanding use of the technology as an option for prospective total
ankle replacement candidates.
Paragon 28 acquired Additive Orthopaedics in June 2021,
providing the Company with the first and only FDA approved Patient
Specific Total Talus replacement for treatment of avascular
necrosis (AVN). With approval of the IDE to support future
regulatory applications, the company’s SMART Total Talus is on the
path to become the only device on the market intended for talar
replacement in the setting of adjacent joint arthritis.
Paragon 28’s CEO, Albert DaCosta, commented, “The approval of
this IDE study is another great example of our commitment to
improve the lives of patients suffering from foot and ankle
conditions, and it is an important advancement for our SMART 28
ecosystem and total ankle portfolio. We are very pleased that the
FDA has recognized the potential benefits of expanding access of
this technology to more ankle patients, and we are excited to get
this IDE study underway.”
Paragon 28 extends its gratitude to the FDA for their guidance
throughout this IDE approval process and looks forward to further
collaboration with the FDA and healthcare professionals and
institutions participating in the IDE study.
About Paragon 28, Inc.
Based in Englewood, CO., Paragon 28, is a leading medical device
company exclusively focused on the foot and ankle orthopedic market
and is dedicated to improving patient lives. From the onset,
Paragon 28® has provided innovative orthopedic solutions,
procedural approaches and instrumentation that cover a wide range
of foot and ankle ailments including fracture fixation, forefoot,
ankle, progressive collapsing foot deformity (PCFD) or flatfoot,
Charcot foot and orthobiologics. The company designs products with
both the patient and surgeon in mind, with the goal of improving
outcomes, reducing ailment recurrence and complication rates, and
making the procedures simpler, consistent, and reproducible.
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Investor Contact: Matt Brinckman Senior Vice President, Strategy
and Investor Relations (720) 912-1332 mbrinckman@paragon28.com
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