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 advancing rapidly. Due to the less invasive approach, transcatheter techniques have replaced surgery as standard procedure for a number of complicated interventional procedures. Evolving interventional techniques allow treatment of rhythm disorders, paravalvular leaks, ventricular septal defects and valve replacement. Until recently, therapy for these diseases was limited to patients in whom severe comorbidities lead to contraindications to surgery. Cardiosolutions Dexterity™ Steerable Introducer simplifies many of these procedures and could provide lower cost, less invasive procedures leading to superior patient results.

About Cardiosolutions, Inc.
Cardiosolutions, Inc. ("Cardiosolutions" or the "Company") www.cardiosolutionsinc.com  is developing a less invasive, percutaneous alternative to open heart surgical repair of the mitral valve. The Dexterity™ Steerable Introducer System and Mitra-Spacer™ could provide a long-term therapeutic substitute to this complicated open heart valve repair procedure. In this connection, it would address the unmet clinical need for a minimally invasive solution to the nearly 200,000 patients diagnosed annually with moderate to severe mitral regurgitation who currently forgo treatment because they cannot tolerate a highly invasive procedure. The Company is another novel medical device technology incubated within and spun out of STD Med, Inc. (Stoughton MA.) partnering with BioVentures Investors, a leading Medtech venture firm.  


'/>"/>
SOURCE Cardiosolutions, Inc.
Copyright©2012 PR Newswire.
All rights reserved

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:6/26/2016)... , June 27, 2016 Jazz Pharmaceuticals ... waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of ... acquisition of Celator Pharmaceuticals, Inc. ("Celator"; Nasdaq: ... p.m. (Eastern Daylight Time). As previously announced ... into a definitive merger agreement under which Jazz Pharmaceuticals ...
(Date:6/24/2016)... SOUTH SAN FRANCISCO, Calif. , June 24, ... GBT ), a biopharmaceutical company developing novel ... with significant unmet needs, today announced the closing ... 6,400,000 shares of common stock, at the public ... the shares in the offering were offered by ...
(Date:6/24/2016)... June 24, 2016 Dehaier Medical Systems Ltd. ... which develops, markets and sells medical devices and wearable ... signed a strategic cooperation agreement with Hongyuan Supply Chain ... Chain") on June 20, 2016, to develop Dehaier,s new ... cooperation agreement, Dehaier will leverage Hongyuan Supply Chain,s sales ...
Breaking Medicine Technology:
(Date:6/25/2016)... ... 2016 , ... Conventional wisdom preaches the benefits of moderation, whether it’s a ... the bar too high can result in disappointment, perhaps even self-loathing. However, those who ... , Research from PsychTests.com reveals that behind the tendency to set ...
(Date:6/24/2016)... ... 2016 , ... June 19, 2016 is World Sickle Cell Observance Day. In ... benefits of holistic treatments, Serenity Recovery Center of Marne, Michigan, has issued ... Sickle Cell Disease (SCD) is a disorder of the red blood cells, which can ...
(Date:6/24/2016)... ... ... Global law firm Greenberg Traurig, P.A. announced that 20 Florida attorneys are recognized ... this recognition are considered among the top 2 percent of lawyers practicing within the ... this year’s Legal Elite Hall of Fame: Miami Shareholders Mark D. Bloom, Burt ...
(Date:6/24/2016)... ... 24, 2016 , ... Topical BioMedics, Inc, makers of Topricin and MyPainAway Pain Relief Products, join ... wage raise to $12 an hour by 2020 and then adjusting it yearly to increase ... of the minimum wage, assure the wage floor does not erode again, and make future ...
(Date:6/24/2016)... , ... June 24, 2016 , ... ... is proud to recognize Dr. Barry M. Weintraub as a prominent plastic surgeon ... beautiful women in the world, and the most handsome men, look naturally attractive. ...
Breaking Medicine News(10 mins):