News

September 2018

Recognizing the lack of funding for pediatric medical device development, PediaVascular held a product pitch competition during the Pediatric & Adult Interventional Cardiac Symposium on September 6, in Las Vegas. Five teams of pediatric cardiologists presented their concepts to a panel of interventional cardiology experts. The winning concept was titled Deflectable Hybrid Sheath from a team at Our Lady’s Children’s Hospital, Crumlin, Ireland.  PediaVascular award the team an unrestricted $25,000 grant to continue development efforts.  The award also included complementary consultations with regulatory, reimbursement, intellectual property, legal and business experts to assist in product commercialization.

 

February 2017
PediaVascular has begun development of a 3Fr. long sheath designed for PDA stenting, coarctation stents and BT shunts.

 

February 2017
PediaVascular has seucred CE marking and has begun a European-wide product launch.

 

October 2015
PediaVascular estimates that physicians now have treated over 10,000 babies with its devices.

 

May 2013

The New York Times discusses the first use of the Mongoose Pediatric Catheter.  New York Time Article 

 

September 2012

PediaVascular secures 510k clearance for Super Sheath introducer sheaths, the first and only introducer sheaths to receive a pediatric indication for use from the FDA.

 

July 2012

PediaVascular secures 510k clearance for Mongoose angiography catheters, the first and only angiography catheters to receive a pediatric indication for use from the FDA.

 

July, 2010

PediaWorks announced the formation of PediaVascular, Inc., a social venture to help alleviate the severe shortage of medical devices for use in pediatric patients.

PediaVascular will be the first and only organization to develop catheters just for children.  For decades the lack of financial incentives has hampered the development of pediatric-specific medical devices.  As a result physicians are often limited in the therapies they can deliver to children.

According to U.S. Senator Sherrod Brown. "Too often, medical devices are not made with children in mind. Because of the unique set of circumstances that discourage innovation in pediatric medical research and development, thinking outside the box becomes a necessity. This important new venture does just that.  This initiative will help ensure that our children have the right medical devices designed for their growing bodies and further cement Cleveland as a hub for medical research and development."