SAN CLEMENTE, Calif.--(BUSINESS WIRE)--
Dallen Medical, Inc., an innovator in bone fixation and repair, today
announced 510(k) clearance from the U.S. Food and Drug Administration
(FDA) for a disposable version of its Compressyn™ Staple Delivery System
for small bone fixation. The disposable system is designed to respond to
clinician demand for a less expensive system that complements its
reusable system and delivers the same superior fixation. This clearance
marks the sixth FDA clearance for the company in the last 18 months.
Dallen Medical’s patented Compressyn technology is the only rigid
compression fixation technology that delivers continual, dynamic
compression for small bone fixation.
The Compressyn system features a proprietary, stainless steel staple
that springs into position upon delivery, providing active tension that
creates strong, consistent compression. The Compressyn staples are more
rigid than nitinol staples, minimizing the risk of splaying and
improving patient outcomes, which may reduce treatment costs and length
of hospital stay. The unique staple design also virtually eliminates
distraction, which has been an issue with competitive stainless steel
“By adding a disposable system to our portfolio, we will be able to
offer hospitals and surgery centers a more affordable option for small
bone fixation without diminishing the system’s superior results, which
responds to current efforts to improve the cost and quality dynamic in
the healthcare system,” said Dallen Medical Chief Executive Officer
David Mills. “The Compressyn Staple is designed to provide surgeons with
the highest standard of rigid compression leading to optimal patient
outcomes, enabling them to provide the best possible care to their
The Company also announced it recently filed a FDA submission for an
acromioclavicular (AC) ligament repair device for shoulder separation as
part of its Tensyn band product line. The Tensyn technology offers
proprietary, knotless banding for stabilized fixation of the ankle and
other anatomy that does not require rigid compression.
About Dallen Medical, Inc.
Dallen Medical is an early-stage orthopedic company whose patented
technology provides superior fixation and compression. The Company has
seven FDA clearances around its Compressyn™ and Tensyn™ technologies and
is targeting underserved markets where it can deliver a higher standard
of rigid fixation and compression, where warranted, without compromising
speed or ease of use. For more information, visit www.dallenmedical.com.
Michelle McAdam, 310-902-1274
Source: Dallen Medical, Inc.