Lifetech launches post-market LAA device study

July 5, 2017 By Fink Densford

LifeTech Scientific said this week it is launching a 3-year post-market surveillance study of its LAmbre left atrial appendage closure system.

The Chinese developer said it plans to enroll 500 patients in the study at 30 clinical centers across Europe, Asia and South America.

“New devices have been developed to make the procedure even safer and more effective. The Lambre device is one of these new systems, with several major advantages” trial primary investigator Horst Sievert said in a prepared statement.

The LAmbre system is designed for the closure of the LAA percutaneously through a small 8 to 10 Fr sheath, and consists of a distal umbrella and a proximal cover disc connected by a short sleeve, LifeTech said. The device is fully recapturable and repositionable, the company added.

“We are also about to start an IDE trial on Lambre device in the US. The clinical safety records and the advanced design of the device make us very confident to survive and grow from the head to head competition in the area,” CEO Xie Yuehui said in a prepared statement.

LifeTech Scientific won CE Mark approval in the European Union for the device last June, touting it as the 1st Chinese-developed LAA closure system to receive such approval.

A closer look at a microrobot that could treat a rare brain malformation
Los Angeles–based startup Bionaut Labs emerged from stealth mode earlier this year to announce its intent to use drug-filled microrobots to treat certain cancers. The company has now secured a humanitarian use device designation from FDA to use a microrobot known as BNL-201 to treat Dandy-Walker syndrome, a rare brain malformation. In 1914, neurosurgeon Walter… […]
Heraeus buys Mo-Sci and ETS Technology Holdings
The Heraeus Group has a deal to acquire Mo-Sci Corp. and ETS Technology Holdings, the Germany-based conglomerate announced this week. Mo-Sci is a supplier of glass microspheres, fibers and powders for medical devices, while ETS is the developer of bioactive glass fiber wound care product Mirragen, an FDA-cleared resorbable synthetic skin substitute. The companies —… […]
Medical Alley appoints new CEO
The Medical Alley Association announced today that it appointed Roberta Dressen as its new president and CEO. Dressen takes over the position previously held by Shaye Mandle since 2014 before he announced his departure for the Biotechnology Innovation Organization (BIO) in February. Steffen Hovard served as interim CEO in the time since then. Get the full… […]
Westfall Technik names Mark Gomulka as CEO
Westfall Technik’s board of directors has nominated Mark Gomulka to lead the company. Gomulka joined the Las Vegas–based plastics manufacturer as SVP in January 2020. Before that, he led Flex’s medical and precision plastics operations for five years and earlier spent 15 years at Nypro in various global operational and leadership roles. In those positions… […]
The MedTech Conference by AdvaMed to be a mixture of in-person and virtual
To hold an event or not to hold a live event. Medtech trade association AdvaMed chose both for The Medtech Conference, which takes place next week. The September 27–30 conference includes a mixture of virtual presentations and in-person events in Washington, D.C., and Minneapolis. AdvaMed CEO Scott Whitaker mentioned several conference agenda highlights during a… […]
Varta launches online battery monitoring feature
Battery maker Varta has launched a cloud computing feature to let customers remotely monitor battery charging, health and the temperature of the battery management system. While Varta makes microbatteries for medical devices such as hearing aids, the new online monitoring dashboard is meant for its “Easy Block” and “Easy Blade” modular smart batteries. The smart… […]
Bionaut Labs wins humanitarian use device designation to treat rare pediatric brain disorder
Microrobotics startup Bionaut Labs has announced that FDA has granted a humanitarian use device designation for the device known as BNL-201 to treat Dandy-Walker syndrome, a congenital brain malformation affecting the cerebellum. According to the National Organization for Rare Disorders, the syndrome affects one out of every 25,000 to 35,000 live births. There are currently… […]
Integer plans $30 million innovation and manufacturing facility in Galway
Integer Holdings Corp. (NYSE: ITGR) plans to build a medical device innovation and manufacturing facility in the Parkmore East area of Galway, Ireland. Plano, Texas–based Integer said the initial phase of the project will total 60,000 square feet and a $30 million investment over the coming years, with construction scheduled from 2022 to late 2023… […]
Accu-Tube appoints Matthew Haddle as CEO
Accu-Tube today announced that it has appointed Matthew Haddle as its new CEO. Prior to joining the Englewood, Colorado-based company, Haddle was GM of industrial coating services and equipment at Praxair Surface Technology. He has also held senior management positions at Albany Engineered Composites and Accellent. Get the full story on our sister site, Medical… […]
LightDeck picks GS Plastic Optics for COVID-19 test ramp up
LightDeck Diagnostics has selected GS Plastic Optics to make optical components for its new COVID-19 antibody testing platform. Boulder, Colorado–based LightDeck developed a screening platform to deliver results as quickly as five minutes for SARS-CoV-2 ultra-rapid antigen and COVID-19 total antibody tests, using a laser waveguide with a consumable cartridge for each testing sample. Rochester,… […]
Hologic’s first Global Women’s Health Index flags preventative care for improvement
An estimated 1.5 billion women have not been tested in the past year for critical diseases, according to Hologic’s first Global Women’s Health Index. On behalf of diagnostic maker Hologic, the Gallup World Poll surveyed more than 60,000 women and girls (age 15 and older) across the world to measure action and attitudes about women’s… […]