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 ben
'/>"/>

SOURCE Intact Medical Corporation
Copyright©2008 PR Newswire.
All rights reserved

Page: 1 2

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:8/28/2014)... Aug. 28, 2014  Next month, executives from clinical trial ... industry events beginning with Patient-Centered Clinical Trials 2014 , ... Boston , September 4-5. Patient recruitment experts ... Aaron Fleishman will share insights on the benefits of ... of tactics – from media to mobile apps – can ...
(Date:8/28/2014)... Sterlitech is proud to announce that it is ... of products . These additional products increase the ... filters with surface charges. , “We have ... membrane process testing equipment, and correspondingly, a wider demand ... Sterlitech President Mark Spatz. “The addition of Synder ...
(Date:8/28/2014)... TALLAHASSEE, Fla. Exciting new work by a Florida ... molecular system that can take your temperature, emit white ... , And, the molecule looks like a butterfly. , ... and Biomedical Engineering in the FAMU-FSU College of Engineering, ... ago, but has continued to discover that his creation ...
(Date:8/28/2014)... Vt. (PRWEB) August 28, 2014 ... testing around the world is available from Strategic ... diagnostics companies. “ Industrial Microbiology Market Review, Fourth ... Industrial Market ” (IMMR—4) tracks and compares microbiology ... in North America, Europe and Asia, and forecasts ...
Breaking Biology Technology:BBK Worldwide Leads Sessions at Key September Events 2Sterlitech Corporation Enhances Its Selection of Flat Sheet Membrane Filters 2Novel 'butterfly' molecule could build new sensors, photoenergy conversion devices 22 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 22 Billion Industrial Microbiology Tests Conducted for Product Quality and Safety Worldwide 3
... - Wisconsin manufacturers made $215 million in efficiency ... Wisconsin Manufacturers Extension Partnership (WMEP) during the organization's last ... is a state-supported, non-profit organization providing consulting services to ... was based on a survey of its clients. It ...
... - The Wisconsin Economic Summit served its purpose ... four summits that took place between 2000 and 2003 ... that are shaping the state's growth. But once those ... to do something about them, the Wisconsin Economic Summit ...
... conference on protecting the U.S. food supply from terrorism and ... until spring from its original November dates. , ,The ... 1-3 in downtown Milwaukee, with as many as 1,000 people ... David Duecker, who, with the Wisconsin Procurement Institute, is helping ...
Cached Biology Technology:Manufacturing group says efforts led to big improvements 2Forum builds on the work of the Wisconsin Economic Summit 2Forum builds on the work of the Wisconsin Economic Summit 3
(Date:8/28/2014)... that an expansion of marine protected areas is needed ... According to investigators from the Wildlife Conservation Society ... focused on saving the largest numbers of species, often ... and difficult-to-replace ecological functions. , Many vital ... species that also are food for millions of people. ...
(Date:8/28/2014)... MARC (Maximizing Access to Research Careers) Program has announced ... Human Genetics from October 18 22, 2014 in ... promote the entry of students, post doctorates and scientists ... science community and to encourage the participation of young ... This year MARC conferred 16 awards totaling $29,600., The ...
(Date:8/28/2014)... FASEB MARC (Maximizing Access to Research Careers) Program ... Genetics Society of America,s 27th Annual Mouse Molecular ... 2014 in Pacific Grove, California. These awards ... post doctorates and scientists from underrepresented groups into ... to encourage the participation of young scientists at ...
Breaking Biology News(10 mins):Study finds marine protected areas inadequate for protecting fish and ocean ecology 2
... embryonic stem cell lines accumulate changes in their genetic material ... utility of the cells for some types of research or ... attention to the need to closely monitor stem cell lines ... the cells' behavior. The researchers' work is described in the ...
... Americans will be diagnosed with melanoma this year, says ... will be fatal. If not caught in the early ... cancer, spreading through the body with an efficiency that ... Biomedical Research have discovered one of the reasons why ...
... from Johns Hopkins have discovered the presence of functional ... ion channels act like electrical wires and permit ESCs, ... all cell types of the body, to conduct and ... block some of these channels in implanted cells, derived ...
Cached Biology News:Embryonic stem cells accrue genetic changes 2Embryonic stem cells accrue genetic changes 3Embryonic stem cells accrue genetic changes 4Researchers discover why melanoma is so malignant 2Researchers discover why melanoma is so malignant 3Stem cells' electric abilities might help their safe clinical use 2
...
Denhardt's powder mixture (for 50X stock solution)...
... SYBR Green Mixes are optimised for SYBR Green ... to perform Quantitative PCR, with the exception of ... Mix contains optimal levels of active SYBR Green ... a proprietary reaction buffer that enables detection of ...
... The Vibratome Roto-Shake Genie is an ... It performs five different mixing ... and rotating/rolling, as well as a ... The precision-engineered moving portion of the ...
Biology Products: