Navigation Links
Cardiosolutions, Inc. Receives FDA 510(k) Clearance for Dexterity™ Steerable Introducer
Date:6/13/2012

WEST BRIDGEWATER, Mass., June 13, 2012 /PRNewswire/ -- Cardiosolutions Inc., an emerging leader in structural heart solutions for valvular heart disease, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market its  Dexterity™ Steerable Introducer, a next generation structural heart access introducer and delivery conduit. The Dexterity™ Steerable Introducer is designed to provide physicians straightforward and uncomplicated access to the heart anatomy by simplifying the cardiac trans-septal procedure and facilitating passage of therapies into the entire left atrium, left ventricle and associated heart structures. The Dexterity™ Steerable Introducer is intended to be used for the advancement and delivery of various cardiovascular catheters into the heart, including the left side of the cardiac anatomy through the inter-atrial septum.

Dr. Thomas Piemonte, Chief Medical Officer for Cardiosolutions and Director, Interventional Cardiovascular Medicine and Cardiac Catheterization Laboratory at the Lahey Clinic in Burlington Massachusetts stated, "The Dexterity™ Steerable Introducer is an exciting, versatile product that permits unparalleled access to the heart chambers. We believe it is an ideal and essential tool for the Interventional or Electrophysiology physician who needs precise catheter placement with combined ease of use." Steven Tallarida, President and CEO of Cardiosolutions further offered, "The ability to generate revenue from our Dexterity™ Steerable Introducer, while simultaneously advancing the development of our Mitra-Spacer™ technology shows our ability to create value early in the startup cycle.  We now have a specialty introducer product that complements the development of the Mitra-Spacer™, a potential blockbuster device that is intended to mitigate mitral regurgitation."

Transcatheter therapy of structural heart disease is
'/>"/>

SOURCE Cardiosolutions, Inc.
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2

Related medicine technology :

1. Cochlear Americas Receives FDA Approval of the Worlds Thinnest, Full Length Electrode for Cochlear Implantation
2. CSL Behring Receives FDA Orphan Drug Designation for rIX-FP, a Novel Therapy in Development to Treat Congenital Factor IX Deficiency (Hemophilia B)
3. PharmaNet/i3 Receives Distinguished Partner Award from the US Chinese Anti-Cancer Association
4. ViewRay Receives FDA 510(k) Clearance for MRI-Guided Radiation Therapy System
5. Breathe Technologies Non-Invasive Open Ventilation (NIOV™) System Receives Medical Design Award
6. The Largest Private Funder Of Melanoma Research Receives Vital Support From Activist Jeffrey Epstein
7. HeartWare International Receives CE Mark Addendum, Expanding Label to Include All Patients at Risk of Death From Refractory, End-Stage Heart Failure
8. Minacs Receives New URAC Pharmacy Benefit Management Accreditations
9. TriReme Medical, Inc. Receives FDA Approval for Glider™ PTCA Catheter
10. Perrigo Receives FDA Approval for Butoconazole Nitrate 2% Vaginal Cream
11. InfuSystem Holdings, Inc. Receives Letter From NYSE MKT Regarding Timely Notice Of Record Date For 2012 Annual Meeting Of Stockholders
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/24/2014)... Dec. 23, 2014 PuraMed BioScience®, Inc., (OTC ... (OTC) medicinal and healthcare products, announced it received the ... a hemp-based, advanced headache relief product, for planned distribution ... Colorado , Washington State ... With the MigraPure H Advanced headache relief gel formulation ...
(Date:12/24/2014)... , December 24, 2014 ... on Global Disposable Syringe Industry of 178 ... online business intelligence library. The ... Syringe Industry is a professional and deep ...  For overview analysis, the report introduces Disposable ...
(Date:12/24/2014)... , Dec. 23, 2014  The American ... blood pressure target for people with diabetes and ... or high doses of statins, in keeping with ... enacted by the American College of Cardiology (ACC) ... reflected in the most recent changes to the ...
Breaking Medicine Technology:PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 2PuraMed BioScience Nears Final Stages Needed for Distribution of MigraPure H 3World Disposable Syringe Market 2014 Report: China and Regional Analysis 2World Disposable Syringe Market 2014 Report: China and Regional Analysis 3World Disposable Syringe Market 2014 Report: China and Regional Analysis 4World Disposable Syringe Market 2014 Report: China and Regional Analysis 5New Standards of Care Provide Guidelines for Statin Use for People with Diabetes to Prevent Heart Disease 2New Standards of Care Provide Guidelines for Statin Use for People with Diabetes to Prevent Heart Disease 3New Standards of Care Provide Guidelines for Statin Use for People with Diabetes to Prevent Heart Disease 4
(Date:12/24/2014)... News) -- Longer and colder body cooling does not reduce ... from a lack of oxygen, a new study finds. ... condition -- called hypoxic ischemic encephalopathy -- can be reduced ... Fahrenheit) for 72 hours, experts say. Research has shown ... so this study examined if the same would be true ...
(Date:12/24/2014)... Dec. 23, 2014 (HealthDay News) -- Though most patients ... medication and therapy, between 10 percent to 20 percent ... to standard care, experts say. However, patients with ... form of a type of brain surgery that disables ... The challenge: to distinguish between patients most likely to ...
(Date:12/24/2014)... you are a high-risk heart patient, you might be ... cardiologist, new research suggests. Survival rates among these ... professional meetings, Harvard researchers report. Sixty percent of ... teaching hospital during one of these meetings died within ... were not taking place. "That,s a tremendous reduction ...
(Date:12/22/2014)... December 22, 2014 As part ... senior care service in San Diego and ... of its senior care team with ongoing online ... Golden Care is provided by Caregiverlist®. Caregiverlist® ... caregivers with the most reliable eldercare options, highest ...
(Date:12/22/2014)... Los Angeles, CA (PRWEB) December 22, 2014 ... the names have changed. The reason why most fad ... work - temporarily. The problem with fad diets is that, ... loss tapers, leaving the dieter uncertain of how to reset ... mode. For this reason, Diet Doc developed their all-inclusive ...
Breaking Medicine News(10 mins):Health News:Greater Cooling of Oxygen-Deprived Infants Fails to Improve Survival 2Health News:Scans May Spot People Who'll Benefit From Surgery for OCD 2Health News:When Heart Docs Are Away, Their High-Risk Patients May Fare Better 2Health News:When Heart Docs Are Away, Their High-Risk Patients May Fare Better 3Health News:Golden Care Partners with Nationally Recognized Caregiver Training Service 2Health News:Diet Doc Announces the Difference Between Fad Diets and Real Weight Loss Programs to Help Dieters Make the Best Choice 2Health News:Diet Doc Announces the Difference Between Fad Diets and Real Weight Loss Programs to Help Dieters Make the Best Choice 3Health News:Diet Doc Announces the Difference Between Fad Diets and Real Weight Loss Programs to Help Dieters Make the Best Choice 4
... Minyard Food Stores Inc. is offering any,expectant mom ... Life Healthy(TM)" initiative, the company announced,today., Just in ... will,offer free prenatal vitamins to all expectant mothers for ... any Carnival, Minyard or,Sack,n Save store in North Texas. ...
... and other hospital and healthcare advocates from across the,state ... protest the nearly $300,million in healthcare cuts proposed in ... Gone Tomorrow," a Rally to Preserve Our Healthcare, ... WHEN: 12 noon, May 12, The "Care Today, ...
... Consumer,Healthcare, marketer of the leading smoking cessation products ... applauds,the release of the updated 2008 U.S. Public ... Dependence. Too many smokers lower their,chances of quitting ... The Guideline is an important validation of the ...
... Vaccinogen Inc. said Dutch health,authorities licensed it to manufacture ... to more than $100 million of,potential European sales., ... Emmen, The,Netherlands also paves the way to its pivotal ... before the vaccine can be sold in the United,States., ...
... 7 Hamline University School of Law,s,Health Law Institute ... offer a Health Care Corporate Compliance Certificate,education program. Hamline,s ... the Upper Midwest and one of only four programs ... program is designed to be completed within,one year, with ...
... studies indicate improved IVF procedures may spare patients money & ... ... Calif., May 7 Spurred by recent research,California fertility specialists are ... -- saying newer,and improving in vitro fertilization (IVF) technology tends to ...
Cached Medicine News:Health News:Expectant Moms Offered Free Prenatal Prescription Vitamins at D-FW Area Carnival, Minyard and Sack'n Save Stores 2Health News:A Statement from GlaxoSmithKline Consumer Healthcare on 2008 Update to the U.S. Public Health Service Guideline on Treating Tobacco Use and Dependence 2Health News:A Statement from GlaxoSmithKline Consumer Healthcare on 2008 Update to the U.S. Public Health Service Guideline on Treating Tobacco Use and Dependence 3Health News:Dutch Authorize Manufacture of Vaccinogen's New Cancer Vaccine; License Clears Path to European Production, Final FDA Trial 2Health News:Fertility Doctors: Studies Suggest Artificial Insemination Increasingly Second Choice 2
... detection and semi-quantitation of ... antigen in serum as ... diagnosis of autoimmune disease. ... performed either manually or ...
... for the detection and quantitation ... nuclear antigens (ENA) [RNP, Sm, ... in human serum. SS-A (Ro) ... in the diagnosis of SLE, ...
... Enzyme-linked immunosorbent assays for ... IgG antibodies to extractable nuclear ... human serum. SS-A (Ro) and ... the diagnosis of SLE, subacute ...
... Inc. ENA Screen ELISA test system is ... antibodies to extractable nuclear antigens (anti-ENA) in ... directional insert, this test system is capable ... such as those against Jo-1, Sm, Sm/RNP, ...
Medicine Products: