Thoracic Insufficiency Syndrome Solution Upgraded from HDE to 510(k) Cleared

J&J’s DePuy Synthes Spine tells us it has received U.S. FDA 510(k) clearance to market the VEPTR®/VEPTR II™ Vertical Expandable Prosthetic Titanium Rib Devices for the treatment of Thoracic Insufficiency Syndrome (TIS).

Background

TIS is defined as the inability of the thorax to support normal respiration or lung growth. It is a rare, congenital condition where severe deformities of the chest, spine or ribs impair breathing and lung growth in children. Sufferers include patients with progressive congenital, neuromuscular, idiopathic, or syndromic scoliosis.

The aim of surgery, while being highly patient specific, is to stabilize and straighten the spine, and to create a separation between ribs to potentially improve breathing and enable normal lung growth and development. To this end DePuy Synthes Spine has developed the VEPTR and VEPTR II Devices, indicated for skeletally immature patients with severe, progressive spinal deformities and/or three dimensional deformity of the thorax associated with or at risk of TIS.

These systems comprise curved titanium rods that are surgically attached to the ribs, spine or pelvis to stabilize and straighten the spine. As well as creating that aforementioned separation, after an initial procedure, VEPTR/VEPTR II Devices are lengthened as a child grows using minimally invasive techniques.

The company points to potential benefits of treatment with the VEPTR/VEPTR II Devices, including more normal growth patterns without spinal growth limitations, decreased deformity of the spine, more room for the lungs to grow, increased amount of daily activities because of the increased amount of space for air in the lungs and a decreased need for using ventilators, although treatment results, as with any surgical procedure, can vary from child to child.

The new 510(k) clearance will improve access to the treatment which has only been available under Humanitarian Device Exemption (HDE) regulations since 2004.

Physician comments

“The 510(k) clearance is a great advancement, enabling the VEPTR/VETPR II Devices to now be used at the discretion of the surgeon for spine and chest wall deformities associated with TIS,” said Robert M. Campbell, Jr., MD, Director of the Center for Thoracic Insufficiency Syndrome at The Children’s Hospital of Philadelphia® (CHOP), an inventor of VEPTR/VEPTR II Devices and the first to identify TIS as a disease condition that requires specialized care and treatment. “This will likely increase the availability of the VEPTR Technology for many institutions.”

Company comments

“We are pleased with the FDA’s clearance and the resulting change in regulatory status of the VEPTR/VEPTR II Devices so that more children may benefit from treatment for TIS, a condition where few treatment options exist,” said Max Reinhardt, President, DePuy Synthes Spine. “The device fills a critical need and offers hope for a brighter future for many children.”

Source: DePuy Synthes Spine

 

 

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