Minnesota-based leading medical device major Medtronic, Inc. (MDT) has recently received the 510(k) clearance from the U S Food and Drug Administration (FDA) for its SHILLA Growth Guidance System in the U.S.
This system is based on Medtronic's patent growth-sparing technology, which helps in curing skeletally immature pediatric patients who are less than 10 years old and suffer from acute early-onset scoliosis.
Following this news, Medtronic's share price gained 0.8% to eventually close at $63.85 on Friday.
Scoliosis
Scoliosis is a kind of spinal deformity that causes one's spine to curve sideways. Early-onset scoliosis (EOS) refers to a significant spinal curvature that affects the pediatric population primarily below five years old.
This deformity is a progressive one and tends to have a detrimental effect on EOS patients. Currently, surgical interventions used in EOS therapy are distraction-based systems which require periodic rod lengthening procedures, typically every 6-9 months.
SHILLA Growth Guidance System
Medtronic's SHILLA Growth Guidance system is a unique, updated technology that offers deformity correction while allowing constant natural body growth in affected children. This system reduces the need for extended periodic surgical procedures for EOS patients and can be removed once the patient has attained skeletal maturity.
This system employs a distinctive non-locking set screw at the proximal and distal portions of the construct's rod. The SHILLA System construct provides spinal stabilization and maintains curve correction while allowing for vertical spinal growth.
The technology has already been launched in Europe with the receipt of the CE (Conformité Européenne) Mark in 2012. Since then, 17 countries in 3 continents have been using this system.
To date, traditional treatment of long-term scoliosis involved spinal fusion. However, for children, this surgical procedure is deemed a life-threatening one.
With the SHILLA Growth Guidance system now authorized in the U.S., physicians will be able to efficiently handle spinal curvature in EOS patients while maintaining the child's inherent growth.
Zacks Rank
Medtronic presently carries a Zacks Rank #3 (Hold). Better-ranked stocks in the medical products industry include ICU Medical, Inc. (ICUI), Abaxis, Inc. (ABAX) and Conatus Pharmaceuticals Inc. (CNAT). While ICU Medical sports a Zacks Rank #1 (Strong Buy), Abaxis and Conatus hold a Zacks Rank #2 (Buy) each.
Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report
To read this article on Zacks.com click here.
Get all Zacks Research Reports and be alerted to fast-breaking buy and sell opportunities every trading day.
Be the first to comment