The FDA today announced a Class I recall — the most serious kind — for the Medtronic (NYSE:MDT) Harmony delivery catheter system. Medtronic designed the Harmony transcatheter pulmonary valve (TPV) system for treating a leaky native or surgically repaired right ventricular outflow tract (RVOT). It consists of a transcatheter pulmonary valve and a … [Read more...] about Recall of Medtronic’s Harmony delivery catheter is Class I
Catheters
FDA clears Franklin Mountain Medical UltraNav transseptal catheter system
Franklin Mountain Medical this week announced its UltraNav transseptal catheter system has received FDA 510(k) clearance The Phoenix, Arizona-based company designed UltraNav for controlled access and delivery of cardiovascular catheters and guidewires into the heart chambers through a transseptal puncture. The dual-lumen catheter enables … [Read more...] about FDA clears Franklin Mountain Medical UltraNav transseptal catheter system
First patient in the world implanted with Abiomed Impella BTR heart pump
Abiomed (Nasdaq:ABMD) today announced the first patient in the world was successfully treated with its Impella Bridge-to-Recovery (BTR) as part of an early feasibility study. The first implant was performed by Dr. Duc Thinh Pham and Dr. Jane Wilcox at Northwestern Medicine Bluhm Cardiovascular Institute in Chicago. Impella BTR is a forward … [Read more...] about First patient in the world implanted with Abiomed Impella BTR heart pump
MIT researchers think their tube-based device could improve gastrointestinal disorder diagnosis
Researchers from the Massachusetts Institute of Technology have developed a knotted-tube device that could be an easier alternative to gastrointestinal dysmotility diagnostics. The MIT researchers, along with collaborators from Brigham and Women's Hospital, designed a device that comprises a silicone tube filled with liquid metal and knotted … [Read more...] about MIT researchers think their tube-based device could improve gastrointestinal disorder diagnosis
Bendit Technologies’ Bendit21 steerable microcatheter wins FDA clearance
Bendit Technologies today announced it received FDA 510(k) clearance for its Bendit21 microcatheter. The Israel-based company's microcatheter is indicated for use in the treatment of the neuro, peripheral and coronary vasculature. The Bendit21 was granted clearance several months after the successful first use of the neurocatheter in the … [Read more...] about Bendit Technologies’ Bendit21 steerable microcatheter wins FDA clearance
This handheld surgical robot could automate catheter placement
Researchers at the Massachusetts Institute of Technology's Lincoln Laboratory have developed an artificial intelligence-guided ultrasound device to help physicians quickly deploy a catheter at a point of injury. Following traumatic accidents, medical professionals often have to apply life-saving treatment to patients with severe internal … [Read more...] about This handheld surgical robot could automate catheter placement
Applied Plastics adds PTFE Natural coated hypotubes to online webstore
Applied Plastics, a portfolio company of Vance Street Capital, recently announced that it has added PTFE Natural coated hypotubes to its online webstore. PTFE Natural is a proprietary coating process that delivers a lubricious and durable coating to support advanced catheter design, according to the Norwood, Massachusetts–based … [Read more...] about Applied Plastics adds PTFE Natural coated hypotubes to online webstore
Federal Circuit deals Abbott’s St. Jude Medical a setback in catheter IP case
A Federal Circuit court ruled that Abbott (NYSE:ABT) subsidiary St. Jude Medical must face patent infringement claims. Just over one year ago, Abbott’s St. Jude — acquired for $25 billion in 2017 — won a patent dispute over the method for using a double catheter in heart failure patients. Get the full story at our sister site, MassDevice. … [Read more...] about Federal Circuit deals Abbott’s St. Jude Medical a setback in catheter IP case
FDA clears Transit Scientific XO Cross support catheters
Transit Scientific today announced it received FDA 510(k) clearance for its XO Cross support catheter platform for coronary use. Park City, Utah-based Transit Scientific designed the support catheter to deliver pushability, traceability and torque response for improved access in challenging peripheral lesions. It has a non-tapered, metal-alloy … [Read more...] about FDA clears Transit Scientific XO Cross support catheters
Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how
Synchron's catheter delivery could make brain-computer interface technology simpler, safer and more accessible than the leading alternative: open-brain surgery. Officials at Synchron — developer of the catheter-delivered Stentrode brain-computer interface (BCI) implant — believe they're the only BCI company tapping into blood vessels to capture … [Read more...] about Catheter delivery could enable better brain implants: Synchron’s neuroscience chief explains how