Medical Device News Magazine

Colospan Announces FDA Approval of IDE for Intraluminal Bypass Device

An Alternative Approach to Diverting Stoma

About Medical Device News Magazine

About Medical Device News Magazine. We are a digital publication founded in 2008 located in the United States.

Advertise with Medical Device News Magazine! Join Our #1 Family of Advertisers!

We pride ourselves on being the best-kept secret when it comes to distributing your news! Our unique digital approach enables us to circulate your...

Israel based Colospan, which develops novel solutions for colorectal surgery, announced today that the United States Food and Drug Administration (FDA) has approved the company’s investigational device exemption (IDE) application.

Colospan notes with this IDE approval in hand, the company will launch its pivotal study for CG-100, a temporary Intraluminal Bypass Device, designed to reduce diverting stoma rates in patients undergoing gastrointestinal resection procedures.

Anastomotic leak is the most devastating, feared and common complication in colorectal surgery.  When a leak occurs, fecal content can enter the abdominal cavity resulting in potentially serious effects to the patient. Diverting stoma is the current suboptimal gold standard used by surgeons today to avoid the clinical consequences of anastomotic leaks in patients undergoing colorectal surgery. CG-100, Colospan’s lead product, was developed as an alternative approach to diverting stoma. In comparison to a diverting stoma which is usually deployed for 4-6 months and requires a second surgery for removal, Colospan’s CG-100 is deployed for 10 days and can be easily removed under x-ray without the need for a secondary surgical intervention.

Colospan will launch a prospective, randomized pivotal study in Q1 2020, which will be conducted at leading medical centers in the US and Europe and is intended to evaluate the safety and efficacy of the CG-100 to support future regulatory approval in the United States.

Boaz Assaf, Chief Executive officer of Colospan, stated: “We are pleased to have received FDA approval of our IDE application and we look forward to initiating the pivotal study which is a leap forward towards bringing our novel device closer to the market. The pivotal study will allow us to assess the potential of our device to improve patients’ lives, significantly reduce healthcare costs and as a result empower physicians to deliver an improved standard of care. This is a significant milestone for our company as we advance the clinical development of our novel technology in the U.S.”

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine provides breaking medical device / biotechnology news. Our subscribers include medical specialists, device industry executives, investors, and other allied health professionals, as well as patients who are interested in researching various medical devices. We hope you find value in our easy-to-read publication and its overall objectives! Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Other News

HeartFlow Introduces Next Generation Interactive Plaque Analysis Platform to Assess Patient Risk in Suspected Coronary Artery Disease

The HeartFlow Plaque Analysis uses proprietary algorithms to analyze coronary CT angiogram (CCTA) scans, creating a personalized 3D model that quantifies and characterizes plaque volume in the coronary arteries, aiding risk assessment of coronary artery disease. The technology was introduced at the Society of Cardiovascular Computed Tomography (SCCT) Annual Scientific Meeting in Washington, D.C.

Ultrahuman Announces its App Store ‘PowerPlugs’ with the World’s First AFib Detection Technology on a Smart Ring

Recognizing each individual’s health journey is unique, PowerPlugs enable people to choose and focus on the aspects of their health that matter most. It’s designed for highly personalized health insights, ensuring that every individual can personalize their health tracking to their unique needs and goals.

VisionAir Solutions Celebrates Milestone and New Collaboration

This achievement marks VisionAir Solutions commitment to bringing technological innovation to pulmonary medicine. Since its acquisition by Theken Companies last year, VAS has over doubled its growth and continues to demonstrate industry adoption and the advantages of personalized healthcare.