FDA grants clearance to Cook Medical biliary stent
The new stent has an innovative delivery system that gives clinicians more control.
Cook Medical's new Evolution Biliary Controlled-Release Uncovered Stent has been given 510(k) clearance by the Food and Drug Administration (FDA).
The pharmaceutical agency will therefore extend its gastrointestinal (GI) tract stent product line, potentially allowing it to gain a larger share of the market.
According to the organisation, approximately 35,000 metal biliary stents are utilised each year to combat obstructions in the bile duct.
Blockages in the pathway which carries bile from the liver to the gallbladder and small intestine can lead to symptoms such as cysts, gallstones, and inflammation.
The innovative new product has been designed to maintain its shape and stay firmly in place, ensuring a long-term solution for patients and a lower risk of complications.
Cook Medical's revolutionary delivery system works alongside the medical aid to give doctors ultimate control when inserting the stent, ensuring it can be deployed and recaptured easily.
Global leader of the firm's endoscopy division Barry Slowey said: "Now clinicians can experience the same precision and control throughout the entire GI tract from the esophagus to the colon."
Related News
-
News US BIOSECURE Act passed by US House of Representatives
The controversial act, which has already impacted several foreign companies operating in the US, was passed by the House of Representatives on September 9, 2024. It is now headed for the US Senate before it can be signed into law by President Joe Biden... -
News Pharma Supply Chain People Moves
The latest appointments, promotions, and structural changes across the pharmaceutical supply chain. -
News Drug prices agreed upon as part of the US Inflation Reduction Act
The Inflation Reduction Act brought into constitution by the Biden administation in 2022, which proposed a drug price negotiation between the government and pharmaceutical companies, has reached it's first agreement. -
News BIOSECURE Act continues to loom over Chinese pharma manufacturers
With the US BIOSECURE Act on its way to passing into legislation, Chinese companies are facing declining revenues within the first half of 2024 as US pharmaceutical and healthcare companies pull their businesses from the country. -
News Ophthalmologic drug product Eylea faces biosimilar threats after FDA approvals
Regeneron Pharmaceutical’s blockbuster ophthalmology drug Eylea is facing biosimilar competition as the US FDA approves Biocon’s Yesafili and Samsung Bioepis/Biogen’s Opuviz. -
News ONO Pharmaceutical expands oncology portfolio with acquisition of Deciphera
ONO Pharmaceutical, out of Japan, is in the process of acquiring cancer-therapy maker Deciphera Pharmaceuticals for US$2.4 billion. -
News First offers for pharma from Medicare drug price negotiations
Ten high-cost drugs from various pharma manufacturers are in pricing negotiations in a first-ever for the US Medicare program. President Biden’s administration stated they have responded to the first round of offers. -
News Eli Lilly’s Zepbound makes leaps and bounds in weight-loss drug market
In the last week, Eli Lilly has announced their partnership with Amazon.com’s pharmacy unit to deliver prescriptions of Zepbound. Zepbound has also surpassed Novo Nordisk’s Wegovy for the number of prescriptions for the week of March 8.&nbs...
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance