FDA Clears Microline Surgical Flexible Ligating Shears for Advanced Tissue Sealing

  FDA Clears Microline Surgical Flexible Ligating Shears for Advanced Tissue

    First tissue sealing device designed for use with TransEnterix SPIDER®
                               Surgical System

Business Wire

BEVERLY, Mass. -- April 18, 2013

Microline Surgical, Inc., a leading manufacturer of reposable instruments for
minimally invasive surgery, announced today that it has received 510(k)
clearance from the U.S. Food and Drug Administration (FDA) for its Flexible
Ligating Shears, enabling surgeons to effectively cut and seal soft tissue.
The novel flexible nature of the device promises new ways to utilize advanced
energy across a wide range of transluminal and other advanced modes of
surgical access.

Microline’s Flexible Ligating Shears* were designed by the company for use
with TransEnterix’s SPIDER® Surgical Platform*, a system of flexible
articulating channels through which surgeons can simultaneously use multiple
instruments to perform laparoscopic procedures through a single small

“This latest product development advances our MiFusion energy technology
platform, which also includes the MiSeal reposable tissue sealing device. FDA
clearance represents the first of several milestones for a truly unique and
flexible product,” said Microline President & CEO Sharad Joshi.

“Through our collaboration with Microline, we will offer users of our SPIDER®
Surgical System the ability to perform a key function of surgery, tissue
sealing, with a fully flexible instrument offering greater dexterity and
precision,” said TransEnterix President and CEO Todd Pope.

While surgical instruments exist today that articulate in one direction or
another or rotate rigidly, no devices to date have offered surgeons full
deflection for soft tissue cutting and sealing.

Based on Microline’s MiFusion DC resistive direct thermal fusion technology,
the Flexible Ligating Shears is the only cut and seal device featuring a
flexible cable that allows surgeons to gain access to areas of the body
through a host of conduits which can benefit from small, catheter based
technology. With the Flexible Ligating Shears surgeons can twist and turn down
convoluted pathways in the body and position the jaws at virtually any angle
to perform an effective tissue seal.

“This collaborative effort between Microline and TransEnterix is a significant
development that can accelerate the rapidly growing field of laparoscopy,”
said Microline Executive Chairman Dr. Jean-Luc Boulnois. “Now, and in the
future, surgeons will increasingly need transformative technologies that can
help them deliver optimal patient outcomes with fewer costly complications and
the Flexible Ligating Shears are well-positioned to assist in this effort.”

About Microline Surgical
Headquartered in Beverly, Massachusetts, Microline Surgical, Inc. is a leading
U.S. medical device manufacturer of high-quality reposable surgical
laparoscopic instruments. Founded in 1987, Microline is a wholly owned
subsidiary of HOYA Corporation (7741:TSE) in Tokyo, Japan, a $4.5 billion
company with approximately half of its revenues from medical business
including endoscopy and eye care. Microline’s integrated modular laparoscopic
instrumentation system consists of a selection of reusable handpieces that
utilize a broad assortment of disposable tips. This concept allows for
surgical efficiency and cost effectiveness to be preserved at all times. The
company’s patented product portfolio comprises cutting, dissecting, grasping,
cauterizing and ligating instruments used in all laparoscopic surgical
procedures. For more information, visit www.microlinesurgical.com.

*Please refer to individual Instructions for Use for detailed intended use


For Microline Surgical, Inc.
Kara Della Vecchia, 508-314-3127
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