FDA Clears Microline Surgical (Formerly known as Microline PENTAX) Flexible Ligating Shears for Advanced Tissue Sealing

BEVERLY, Mass.--(BUSINESS WIRE)-- 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 incision.

“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 statements.

Contact:

For Microline Surgical, Inc.

Kara Della Vecchia, 508-314-3127

kara@kdvcommunications.com