MMDI's Rebound HRD V Receives FDA 510(k) Clearance - Devices and Research News

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PRESS RELEASE : U.S. and World News : Medical : Devices and Research News

MMDI's Rebound HRD V Receives FDA 510(k) Clearance

Wed, 29 Apr 2009, 11:42:28 EST
Edited by Carly Zander

MINNEAPOLIS, Minn., April 29 (SEND2PRESS NEWSWIRE) -- Minnesota Medical Development, Inc. (MMDI) today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance to its new Rebound HRD® V (Hernia Repair Device). The Rebound HRD V is intended to assist in the repair and/or reinforcement of hernia or other soft tissue defects where weakness exists and where the support of a nonabsorbable material is preferred.

MMDI

MMDI also recently received the CE Mark of Conformance for the design, manufacture and distribution of its Rebound HRD V in European Union member countries.

The Rebound HRD V is a self-expanding Nitinol framed/surgical mesh medical device designed for the laparoscopic repair of ventral and incisional hernias. The super-elastic Nitinol frame allows the device to be folded and inserted laparoscopically through an access port or small incision. Once deployed, the device fully unfurls or "rebounds" back to its original shape - ready for quick and easy placement over the hernia defect. The Rebound HRD V should significantly shorten operating times by reducing fixation and organizing the mesh during the procedure. Although the Rebound HRD V is ideally suited for laparoscopic surgery it may also be placed via an open incisional approach.

"We have spoken with many surgeons who have indicated the need for a better way to laparoscopically repair ventral and incisional hernias. Mesh handling and fixation are procedural issues that make laparoscopic hernia repair time consuming and costly. The Rebound HRD V addresses those issues with its Nitinol frame. Mesh can now be placed more efficiently during the repair - benefitting the patient, surgeon and healthcare facility," said MMDI Chief Marketing Officer, Steve Nuss.

"In the United States alone, approximately 90,000 ventral hernias are repaired annually using surgical meshes. Ventral and incisional hernia repairs are not as common as inguinal repairs, but they are often times more complex and time intensive," he added.

Additional information can be obtained by contacting Steve Nuss, Chief Marketing Officer at 763-354-7105 or snuss@2mdinc.com. You may also visit our website at: www.2mdinc.com.

About MMDI

MMDI was established in 2001 and is based in Plymouth, Minnesota. Located in the heart of Minnesota's "Medical Alley," MMDI has access to some of the world's finest medical product development, manufacturing and marketing resources. The Company's primary objective is to identify, develop, patent and manufacture unique medical devices that provide significant clinical benefits and market opportunities.

NEWS SOURCE: Minnesota Medical Development, Inc.

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REFERENCES: MMDI's Rebound HRD V Receives FDA 510(k) Clearance, Minnesota Medical Development, Inc., Rebound HRD V (Hernia Repair Device, FDA 510k clearance, super-elastic Nitinol frame, surgical mesh medical device, Steve Nuss, S-IND, Apr 29, 2009.

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