Investigational Device Exemption

Type: Keyphrase

Name: Investigational Device Exemption

First reported May 17 2013 - Updated May 17 2013 - 1 reports

Direct Flow Medical wins FDA approval for U.S. trial of new heart valve

Direct Flow Medical wins FDA approval for a U.S. trial of its new transcatheter aortic valve implant.The FDA granted Direct Flow Medical an investigational device exemption for its transcatheter aortic valve implant, with the medical device company announcing ... [Published MassDevice - May 17 2013]

Entities: Heart Valve, Investigational Device Exemption, Aortic Valve, United States

First reported May 16 2013 - Updated May 16 2013 - 1 reports

FDA Grants IDE Trial for Sorin Group Perceval S Sutureless Aortic Valve

Primary objective of the prospective, non-randomized trial is to demonstrate the safety and effectiveness of the Perceval S sutureless valve.May 16, 2013 — Sorin Group has received U.S. Food and Drug Administration (FDA) approval of its Investigational ... [Published Diagnostic & Invasive Cardiology - May 16 2013]

Entities: Aortic Valve, Investigational Device Exemption, Sorin Group SpA

First reported May 16 2013 - Updated May 16 2013 - 1 reports

Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market

SummaryGBI Research’s report “Changing Regulatory and Reimbursement Scenario for Medical Devices in the US Market” looks at the regulatory landscape and reimbursement scenario in the US for four medical device markets: cardiovascular devices, neurostimulation ... [Published MarketResearch.com - May 16 2013]

Entities: Medical Devices, Investigational Device Exemption, endoscopy, Market

First reported May 15 2013 - Updated May 16 2013 - 1 reports

St Jude Medical Inc

Cardiology Center of Amarillo Enrolls First Patient Nationwide in New St. Jude Medical Trial

AMARILLO -- Cardiology Center of Amarillo, LLP announced that it has enrolled and implanted the nation's first patient in a new trial sponsored by St. Jude Medical.Cardiology Center of Amarillo is one of 50 nationwide centers participating in the MultiPoint ... [Published MyHighPlains.com - May 15 2013]

Entities: Amarillo (United States), St Jude Medical Inc, Cardiology

First reported May 16 2013 - Updated May 16 2013 - 1 reports

Australian Securities Exchange

Sunshine Heart Appoints Jon Salveson to Board of Directors

: Sunshine Heart, Inc.(NASDAQ: SSH; ASX: SHC) today announced that Jon W. Salveson has been appointed to the Company’s Board of Directors. Mr. Salveson is the Vice Chairman,Investment Banking and Chairman of the Healthcare Investment Banking Group atPiper ... [Published GBS Venture Partners - May 16 2013]

Entities: SUNSHINE HEART, Australian Securities Exchange, Investment Banking, Piper Jaffray Companies, congestive heart failure

First reported May 15 2013 - Updated May 15 2013 - 1 reports

Biosense Webster Reports Compelling Effectiveness of Force Sensing Thermocool Smartouch Catheter

Catheter and software module enables contact force sensing in the ablation of atrial fibrillationThe Thermocool Smarttouch ablation catheter senses the amount of force the physician is using during an ablation. This can help take the guess work out of ... [Published Diagnostic & Invasive Cardiology - May 15 2013]

Entities: Catheter, Biosense Webster Inc, Ablation, Investigational Device Exemption

First reported May 15 2013 - Updated May 15 2013 - 1 reports

Study Compares Multidisciplinary Convergent Procedure to Endocardial Catheter Ablation to Treat AF

The CONVERGE IDE clinical trial may set a new standard of care in AF ablationMay 14, 2013 — nContact Inc. said it received conditional approval for an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) to begin enrollment ... [Published Diagnostic & Invasive Cardiology - May 15 2013]

Entities: Ablation, Catheter, Investigational Device Exemption

First reported May 14 2013 - Updated May 14 2013 - 2 reports

Boeing Delivers to Mongolia and 2 Other Dow Movers to Watch

The Boeing Company ( NYSE:BA ): Current price $95.78Boeing has delivered a 767-300ER (extended range) to MIAT Mongolian Airlines, marking the first ever direct purchase delivery to the airline. President and Chief Executive of MIAT Mongolian Airlines ... [Published Wall St. Cheat Sheet - May 14 2013]

Entities: Boeing Company, General Electric Company, MIAT Mongolian Airlines, Mongolia

First reported May 13 2013 - Updated May 14 2013 - 8 reports

EDAP's Ablatherm-HIFU Receives Two Best Poster Awards at 2013 American Urological Association Annual Meeting

Four Scientific Sessions Highlighted HIFU for Treatment of Prostate CancerHIFU Featured in Plenary Lecture and Two Moderated Posters at Engineering and Urology Society MeetingSignificant Interest in both HIFU and ESWL Technologies at EDAP BoothLYON, France, ... [Published Morningstar.com - May 14 2013]

Entities: Prostate Cancer, EDAP TMS SA, American Urological Association

First reported May 14 2013 - Updated May 14 2013 - 1 reports

Kips Bay Medical Updates on FDA Status and Posts First Quarter 2013 Results

Kips Bay Medical, Inc. provides an FDA update and announced financial results for its first quarter ended March 30.FDA UpdateAccording to a release, enrollments continue at a modest pace in the Kips Bay eMESH I clinical feasibility trial. As of May 1, ... [Published Zecco - May 14 2013]

Entities: Kips Bay Medical Inc, Investigational Device Exemption, clinical study, Mayo Clinic, Grafting

First reported May 13 2013 - Updated May 13 2013 - 1 reports

Biosense Webster Reports Compelling Results from Ground-Breaking SMART-AF IDE Study on the Safety and Effectiveness of t

DIAMOND BAR, Calif. - (BUSINESS WIRE) - Biosense Webster, Inc., a worldwide leader in the diagnosis and treatment of cardiac arrhythmias, announced the 12-month safety and effectiveness results of the THERMOCOOL SMARTTOUCH Catheter and Software Module ... [Published NewsBlaze - May 13 2013]

Entities: Investigational Device Exemption, Biosense Webster Inc, Catheter

First reported Apr 29 2013 - Updated Apr 30 2013 - 7 reports

Sorin Group to commence sutureless aortic tissue valve study

Sorin Group has received an investigational device exemption (IDE) approval from the US Food and Drug Administration (FDA) to commence a clinical study of its PERCEVAL S sutureless aortic tissue valve. ... [Published Medical Devices Business Review - Apr 30 2013]

Entities: Sorin Group SpA, Investigational Device Exemption, clinical study

Quotes

...Flow's device is designed to address aortic regurgitation by enabling in-situ hemodynamic assessment after the valve is fully deployed, allowing "limitless repositioning with full distal, proximal and planar control, or retrieval, if required" the company claimed

Direct Flow Medical wins FDA approval for U.S. trial of new heart valve [Published MassDevice - May 17 2013]

...company to bring our rigorous clinical research to the U S in order to improve outcomes for patients," said Chief Executive Officer Bernard Lyons. "Our device has shown the ability to achieve excellent outcomes while minimizing the risk of aortic regurgitation in our European trials, and we expect to demonstrate the same in our U S study."

Direct Flow Medical® Receives IDE Approval for U.S. SALUS Trial of Transcatheter Aortic Heart Val ... [Published Business Wire - May 16 2013]

According to Dr. Coty Jewell, "This could be the most important clinical therapy to be introduced in my medical career to date. We have struggled to find a treatment for those people that don't respond to medications and standard device therapies. Multi-Point Pacing offers a potential solution for the failures of prior therapies in the management of heart failure. This could provide the quantum leap in technology that defines my generation of cardiologist."

Cardiology Center of Amarillo Enrolls First Patient Nationwide in New St. Jude Medical Trial [Published MyHighPlains.com - May 15 2013]

"The convergent procedure is the least invasive option among multidisciplinary ablation techniques; there is no chest violation, no"

Study Compares Multidisciplinary Convergent Procedure to Endocardial Catheter Ablation to Treat AF [Published Diagnostic & Invasive Cardiology - May 15 2013]

More Content

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Direct Flow Medical wins FDA approval for U.S. ... [Published MassDevice - May 17 2013]
Direct Flow Medical® Receives IDE Approval for ... [Published Business Wire - May 16 2013]
Direct Flow Medical(R) Receives IDE Approval fo... [Published Zecco - May 16 2013]
Direct Flow Medical® Receives IDE Approval for ... [Published Business Wire Science: Science News - May 16 2013]
Direct Flow Medical® Receives IDE Approval for ... [Published Business Wire Health News - May 16 2013]
FDA Grants IDE Trial for Sorin Group Perceval S... [Published Diagnostic & Invasive Cardiology - May 16 2013]
Changing Regulatory and Reimbursement Scenario ... [Published MarketResearch.com - May 16 2013]
Sunshine Heart Appoints Jon Salveson to Board o... [Published GBS Venture Partners - May 16 2013]
Cardiology Center of Amarillo Enrolls First Pat... [Published MyHighPlains.com - May 15 2013]
Biosense Webster Reports Compelling Effectivene... [Published Diagnostic & Invasive Cardiology - May 15 2013]
Study Compares Multidisciplinary Convergent Pro... [Published Diagnostic & Invasive Cardiology - May 15 2013]
Boeing Delivers to Mongolia and 2 Other Dow Mov... [Published Wall St. Cheat Sheet - May 14 2013]
Boeing Delivers to Mongolia and 2 Other Dow Mov... [Published Wall St. Cheat Sheet - May 14 2013]
Sorin's Smartview remote patient monitoring sys... [Published MassDevice - May 14 2013]
EDAP's Ablatherm-HIFU Receives Two Best Poster ... [Published Morningstar.com - May 14 2013]
Sunshine Heart Announces Corporate Updates and ... [Published Zecco - May 14 2013]
Biosense Webster Enrolls First Patient in reMAR... [Published Equities.com - May 14 2013]
Kips Bay Medical Updates on FDA Status and Post... [Published Zecco - May 14 2013]
Biosense Webster Reports Compelling Results fro... [Published Business Wire - May 13 2013]
Biosense Webster Reports Compelling Results fro... [Published NewsBlaze - May 13 2013]
Trends and Advances in Hemodynamic Support [Published Diagnostic & Invasive Cardiology - May 13 2013]
EDAP Schedules Webcast and Conference Call for ... [Published Equities.com - May 13 2013]
EDAP Schedules Webcast and Conference Call for ... [Published Yahoo! Finance - May 13 2013]
EDAP Schedules Webcast and Conference Call for ... [Published GlobeNewswire - May 13 2013]
EDAP Schedules Webcast and Conference Call for ... [Published Nasdaq - May 13 2013]
EDAP Schedules Webcast and Conference Call for ... [Published Street Insider - May 13 2013]
EDAP Schedules Webcast and Conference Call for ... [Published Zecco - May 13 2013]
EDAP Schedules Webcast And Conference Call For ... [Published TheStreet.com - May 13 2013]
First Patient Enrolled in Study Evaluating the ... [Published Diagnostic & Invasive Cardiology - May 13 2013]
BioControl Medical Launches New Website to Deep... [Published NewsBlaze - May 13 2013]