Tele: 561.316.3330
Breaking Medical Device News

Saturday, October 16, 2021
HomeBrightWater™ MedicalConvertX Biliary Stent System Receives FDA Clearance

ConvertX Biliary Stent System Receives FDA Clearance

ConvertX® Biliary Stent System First Temporary Stent Eliminates Invasive Procedure in Treatment of Biliary Duct Obstructions by Interventional Radiologists

March 25, 2019

ConvertX Biliary Stent System for treatment of biliary obstructions has received FDA clearance. The news was announced today by BrightWater Medical, Inc., a mid-stage medical device company uniquely positioned to significantly impact treatments provided by interventional radiologists.

The biliary ducts carry bile from the liver and gallbladder to the small intestine. Patients with severe duct blockages or difficult anatomies – such as gastric bypass or liver transplant patients — face serious complications including infection, sepsis, biliary cirrhosis or injury to the liver.

Today, most of these patients will either need to undergo two separate one-hour interventional procedures for stent placement or if considered poor candidates for the staged stent procedure, undergo a drain placement instead. If the biliary blockage is managed with a drain, the drain must be exchanged for a new one every 2-3 months, for life.

ConvertX Biliary Stent System is the first system to provide interventional radiologists with a percutaneous plastic biliary stent option. The system is designed to eliminate the need for the second invasive procedure and the associated risk, cost, and time. Rather than a drain-to-stent exchange, the ConvertX System itself enables stent release in less than one minute during an in-office visit or at bedside without the need for sedation or repeated drain insertions.

“Before this, we have had to treat these serious cases without having the right tools,” explained Saher S. Sabri, MD, Director of Interventional Radiology at MedStar Washington Hospital Center and Professor of Radiology at MedStar Georgetown University Hospital. “The ConvertX is a significant paradigm change that enables the IR to be involved in percutaneous temporary plastic stent placement for benign and malignant biliary disease. It allows us to treat with one less invasive procedure for the patient, reducing radiation exposure for the patient and staff.”

Biliary obstructions may be caused by tumors, gallstones, enlarged lymph nodes, cysts or strictures. IRs treat biliary obstructions that are more severe or anatomically challenging, such as in patients with gastric bypass or liver transplants, through two separate one-hour interventional procedures for stent placement.

“The Biliary Stent System was designed by IRs for IRs,” explained ConvertX System developer Bob Smouse, M.D., founder and CEO of BrightWater Medical and Professor of Radiology & Surgery at the University of Illinois College of Medicine. “It is simple to use and deliver with standard interventional techniques and does not require additional physician training. Before the ConvertX, the absence of a percutaneous plastic stent was a huge product gap in the device armamentarium of the IR. According the ACR Practice Guidelines1, a temporary plastic stent is the device-of-choice in 8 out of 9 bile duct blockages and now the IR has that stent option.”

The ConvertX Biliary Stent System is part of BrightWater Medical’s ConvertX Stent Family, which includes the company’s innovative ConvertX Nephroureteral Stent System cleared by the FDA for treatment of ureteral obstructions. That system enables the IR to eliminate a second invasive interventional procedure in treating patients with severe ureteral blockages.

The ConvertX Stent Family was featured at the Advanced Interventional Management (AIM) Symposium in New York City in November 2018 as the lead presentation during the “New and Innovative Technologies” section. BrightWater received its medical device manufacturing license from the California Department of Public Health and manufactures the ConvertX Stent Family at its facility in Temecula, CA.


Reference

1 American College of Radiology, ACR Appropriateness Criteria®: Radiologic Management of Biliary Obstruction, https://acsearch.acr.org/docs/69344/Narrative/

Medical Device News Magazinehttps://infomeddnews.com
Medical Device News Magazine is a division of PTM Healthcare Marketing, Inc. Pauline T. Mayer is the managing editor.

Stay Connected

spot_img

Don't Miss

Ganymed Robotics Awarded a €2.5M Grant from the EC through the EIC Accelerator Program

Ganymed Robotics is developing a radically new approach to surgical robotics by combining computer vision, a branch of artificial intelligence, and mechatronics.

Global Healthcare Exchange Announces Acquisition of Explorer Surgical

Explorer Surgical will operate as a wholly-owned subsidiary of GHX.

Arlington Scientific Broadens Product Portfolio and Further Expands its Product Offering Through the acquisition of Non-Mammalian Blocking Buffers

Arlington Scientific, Inc. (ASI) is pleased to announce that it has acquired the non-mammalian blocking buffer product line from Clark McDermith, former owner of...

Laborie Medical Technologies Acquires Pelvalon

Laborie was represented by Piper Sandler (financial advisor) and Simpson Thacher & Bartlett LLP (legal advisor). Pelvalon was represented by J.P. Morgan Securities LLC (financial advisor) and Dorsey & Whitney LLP (legal advisor).

Herculite Products, Inc. Promotes Two Employees to New Roles

Paul Flaherty Chief Strategy Officer and Marco Angelone is being promoted to the role of Chief Financial Officer.

Prof. Joseph Kvedar Added to the Sweetch Advisory Board Member

Prof. Josdeph Kvedar is the current chair of the board at the American Telemedicine Association (ATA), formerly VP of Connected Health at Mass-Gen Brigham, co-chair of the American Medical Association (AMA) Digital Medicine Payment Advisory Group, and author of The Internet of Healthy Things and The New Mobile Age.

Sid Bala Named President of HealthChampion

Sid Bala is the former president and chief executive officer of alligatortek, a custom software applications company that was acquired by HealthChampion in 2020 where he led them for 27 years after he founded the business

Cochlear Announces FDA Approval and Clearance of first-of-its-kind Remote Care Capabilities for Nucleus and Baha Systems

The FDA approval for the cochlear implant solution and FDA clearance for the Baha solution is the first step in commercializing the product offering, anticipated spring 2022, and complement Cochlear's existing Remote Care offerings.

By using this website you agree to accept Medical Device News Magazine Privacy Policy