Navigation Links
FDA Selects CreatiVasc For New Innovation Pathway Program
Date:4/9/2012

GREENVILLE, S.C., April 9, 2012 /PRNewswire-USNewswire/ -- Greenville-based CreatiVasc Medical has been selected as one of the first three companies for the FDA's new Innovation Pathway program that uses collaboration with innovators to speed important medical devices to market while safeguarding patient safety.

The company has developed an innovative device for dialysis patients, called the Hemoaccess Valve System®, which has the potential to significantly reduce the complications, costly interventional surgery and suffering associated with End Stage Renal Disease patients on dialysis.

The valve system device is now in Phase I human clinical trials. Unlike current dialysis-access graft devices which are prone to clotting and early failure, the CreatiVasc technology is implanted when a patient's access graft is created and allows blood flow to be turned on through the patient's graft only when it is needed for dialysis, then turned off afterward. CreatiVasc and FDA will begin their collaboration in early May.

Company officials said the device could be on the market and available for patients within 24 months.

End Stage Renal Disease, the focus of the first Innovation Pathway, affects more than 571,000 Americans and is considered one of the most costly chronic diseases. Kidney failure and associated dialysis cost the U.S. healthcare system more than $46 billion annually.

Many dialysis patients have a Teflon tube implanted in their arm to provide vascular access for dialysis. Such tubes present a constant challenge because they frequently clot and require costly interventional surgery. According to a study published in the New England Journal of Medicine, more than 75% of dialysis grafts fail and require surgical intervention within the first year after placement. Early research shows that the CreatiVasc Hemoaccess Valve System allows selective blood flow into these grafts only when it is needed for dialysis, which is believed to reduce such universal complications.

The new FDA program will provide a totally new way for medical device companies and FDA to collaborate to assure that promising new technologies are rigorously reviewed but are also guided through its device approval process as rapidly as possible without compromising patient safety.

CreatiVasc was founded in Greenville, S.C., in 2004 by Dr. David Cull, a vascular surgeon with the Greenville Hospital System who developed the new technology after seeing first-hand the problems associated with traditional dialysis-access grafts. The company began full-time operations in 2007. The company has multiple issued patents on the device both in the U.S. and around the world.


'/>"/>
SOURCE Greenville Hospital System
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Weill Cornell Medical College Selects Ingenuity® Variant Analysis™ and Ingenuity® iReport™ for Sequencing Core Facility
2. ASLAN Pharmaceuticals Selects PharmaNet/i3 as Strategic Partner For Oncology Development
3. Rubicon Genomics Selects Velesco to Manufacture its TransPLEX® RNA Amplification Kits for Clinical Diagnostic Use
4. Stryker Communications Selects Glowpoint to Enhance IP Video Platform for Operating Rooms
5. NorthCrest Medical Center Selects Allscripts Sunrise Electronic Health Record
6. Biotechnology Pharmaceutical Company Selects NewCardios QTinno for Thorough QT Trial
7. Mental Health Partners Selects Stockell Healthcares InsightCS® Revenue Cycle Information Management System
8. Global Pharma Selects Semantellis Compliance Ready Social Listening Platform to Manage Corporate Reputation
9. Mammoth Hospital Selects Allscripts RCM Services
10. Inova Selects Beryl as Provider of Outsourced Patient Experience Solutions
11. WHCA Selects COMS Interactive as Affinity Partner
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:9/22/2017)... ROCKVILLE, Md. , Sept. 22, 2017  As ... by Republican Senators Bill Cassidy (R-LA) and ... Kalorama Information notes that the medical device industry is ... the medical device tax, the 2.3% excise tax on ... Act.  But they also want covered patients, increased visits ...
(Date:9/19/2017)... Mich. , Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company ... destruction of targeted tissues, announced three leadership team developments today:   ... PhD ... ... Veteran medical device executive Josh ...
(Date:9/18/2017)... KALAMAZOO, Mich. , Sept. 18, 2017 ... , and OptiMed Specialty Pharmacy of Kalamazoo, ... offer a strategic hub service that expedites and streamlines ... personal spirometer, Spiro PD 2.0, and wellness management services.  ... is a medical device used to measure lung function ...
Breaking Medicine Technology:
(Date:10/13/2017)... ... October 13, 2017 , ... ... PharmD ‘17, and Jennifer Huggins, PharmD ’17, along with clinical associate professor ... prevention of cardiovascular diseases during the 15th Annual Women’s Health Conference. The ...
(Date:10/13/2017)... ... October 13, 2017 , ... Apple Rehab Shelton Lakes , ... mock evacuation of the facility as part of a disaster drill on October 3rd. ... EMS and Shelton City Emergency Manager, as well as the Connecticut Long Term ...
(Date:10/13/2017)... ... ... The Visiting Nurse Association (VNA) of Somerset Hills is proud to host ... items from across the nation, this holiday-themed event will raise funds and awareness for ... The boutique will be open Saturday, November 4 (10:00 a.m. – 5:00 p.m.) ...
(Date:10/13/2017)... ... ... Global Healthcare Management’s 4th Annual Kids Fun Run brought out many kids this ... by Global Healthcare Management’s CEO, Jon Letko, is aimed at getting kids excited about ... ages; it is a non-competitive, non-timed event, which is all about having fun and ...
(Date:10/13/2017)... ... October 13, 2017 , ... Talented host, actor Rob Lowe, ... in a new episode of "Success Files," which is an award-winning educational program ... investigates each subject in-depth with passion and integrity. , Sciatica occurs when the ...
Breaking Medicine News(10 mins):