Navigation Links
Intact Medical Corporation's Intact(R) Excise XL Receives 510(K) Marketing Clearance from the FDA
Date:9/16/2008

NATICK, Mass., Sept. 16 /PRNewswire/ -- Intact Medical Corporation, an emerging leader in the development and marketing of minimally invasive systems for the diagnosis and removal of breast lesions, today announced that it has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the Intact (R) Excise XL - a larger version of the Company's already FDA approved wands, used with the Intact (R) Breast Lesion Excision System (BLES). The Company expects to begin marketing the product to physicians in the fourth quarter of this year.

As with the Intact (R) BLES, the Intact (R) Excise XL procedure involves the insertion of a slender wand through a small incision in the breast to remove an intact sample of suspicious tissue for histopathologic analysis. The procedure can be performed in an office-based or outpatient setting, with the actual capture of the breast lesion completed in less than 20 seconds. To date, over 30,000 Intact (R) BLES procedures have been performed in the U.S. and Europe.

Christopher Bleck, President and Chief Executive Officer of Intact Medical, noted, "With the recent FDA clearance, the Intact (R) Excise XL represents an important line extension, providing greater choice for physicians and patients. Since it allows for extraction of larger, intact breast tissue, it has the potential to provide both a more accurate histopathologic assessment and the complete excision of even larger suspicious lesions. The Excise XL, with its larger capture basket, is a first-line alternative to surgical excision for any suspicious lesion 1.5cm (or smaller) in diameter. Under stereotactic or ultrasound image guidance, the Excise XL permits surgeons to completely excise small lesions along with the potential to evaluate tissue margins in a single, minimally-invasive procedure."

Mr. Bleck continued, "There are over 400,000 surgical breast procedures (excisional biopsies) for initial diagnostic purposes and more than 700,000 benign lesion removals performed in the U.S. each year. Within this population, we expect the introduction of the Excise XL to result in increased usage of the System, as it provides physicians with a greater measure of flexibility in removing and diagnosing suspicious lesions of the breast. The new, larger capture basket will also allow physicians to remove the entire lump with the non-invasive Intact(R) System, versus an open surgical procedure, which is commonly used with larger lesions."

About Intact Medical Corporation

Founded in 1998, and based in Natick, Massachusetts, Intact Medical Corporation is a privately held company focused on the design, development and marketing of innovative, minimally invasive systems for the volumetric excision of tissue for diagnostic and therapeutic applications in select cancer markets. The Company's lead product, the Intact Breast Lesion Excision System, received market clearance from the Food and Drug Administration in June 2001. Initial products are targeted at

breast biopsy and the excision of benign lesions, potentially obviating the need for open surgical excisions. In August 2005, the company received expanded approval for the System, allowing its use to obtain tissue samples for histologic examination with partial or complete removal of an imaged abnormality, or partial removal of a palpable abnormality that has been classified as benign.

For more details on the Company, visit http://www.intactmedical.com

Contact:

Intact Medical Corporation

Christopher Bleck, President & CEO

508-655-7820

Rx Communications Group

Paula Schwartz (investors) 917-322-2216

Eric Goldman (media) 917-322-2563


'/>"/>
SOURCE Intact Medical Corporation
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. AEterna Zentaris completes management team with the appointment of Chief Medical Officer
2. VisEn Medical Files Action to Invalidate New Caliper Life Sciences Patent
3. China Medical Technologies to Participate in the Morgan Stanleys 2007 China Medical Corporate Day
4. Pathway Medical Technologies Adds Joe Rafferty as VP, Sales, and Moves To Larger Facility to Accommodate Rapid Growth
5. BioMS Medical announces its intention to renew a normal course issuer bid
6. Dr. Amit Dhawan Promoted to Medical Director for The Mattson Jack Group
7. ATS Medical Expands Open Pivot Heart Valve Offerings
8. AGA Medical Corporation Receives FDA and CE Mark Approvals for the AMPLATZER Vascular Plug II
9. Globus Medical Announces Record 2nd Quarter 2007 Results
10. IDM Pharma Names Dr. Jeffrey W. Sherman Chief Medical Officer and Senior Vice President of Research and Development
11. China Medical Technologies Reports First Quarter Financial Results
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/23/2016)... , ... June 23, 2016 , ... STACS DNA Inc., ... Leader at the Arkansas State Crime Laboratory, has joined STACS DNA as a Field ... DNA team,” said Jocelyn Tremblay, President and COO of STACS DNA. “In further expanding ...
(Date:6/23/2016)... -- Andrew D Zelenetz , ... Published recently in Oncology & ... Andrew D Zelenetz , discusses the fact ... placing an increasing burden on healthcare systems worldwide, ... the patents on many biologics expiring, interest in ...
(Date:6/23/2016)... ... June 23, 2016 , ... Velocity Products, ... tools designed, tuned and optimized exclusively for Okuma CNC machining centers at The ... of a collaboration among several companies with expertise in toolholding, cutting tools, machining ...
(Date:6/22/2016)... -- Research and Markets has announced the addition of ... offering. The global biomarkers ... in 2013. The market is expected to grow at a five-year ... increasing from $50.6 billion in 2015 to $96.6 billion in 2020. ... period (2015 to 2020) are discussed. As well, new products approved ...
Breaking Biology Technology:
(Date:3/23/2016)... 2016 Einzigartige ... und Stimmerkennung mit Passwörtern     ... MESG ), ein führender Anbieter digitaler Kommunikationsdienste, ... SpeechPro zusammenarbeitet, um erstmals dessen Biometrietechnologie einzusetzen. ... Möglichkeit angeboten, im Rahmen mobiler Apps neben ...
(Date:3/22/2016)... OTTAWA, Ontario , PROVO ... 2016 Newborn Screening Ontario (NSO), which operates ... for molecular testing, and Tute Genomics and ... process management technology respectively, today announced the launch of ... new next-generation sequencing (NGS) testing panel. ...
(Date:3/18/2016)... --> --> Competitive Landscape Analysis ... Physical infrastructure and Perimeter Surveillance & Detection Systems ... and the continuing migration crisis in the Middle ... led visiongain to publish this unique report, which is crucial ... & security companies in the border security market and the ...
Breaking Biology News(10 mins):