Transit Scientific today announced that it received CE mark approval for its non-tapered metal alloy XO CrossO Microcatheter platform. The XO Cross platform is made to deliver pushability, traceability and torque response for improved access in challenging peripheral lesions. It has a non-tapered, metal-alloy and polymer construction that … [Read more...] about Transit Scientific microcatheter wins CE mark approval
Catheters
Catheter & Medical Design acquires VitalDyne Medical
Catheter and Medical Design today announced that it has acquired VitalDyne Medical for an undisclosed amount. Through the acquisition, Catheter and Medical Design takes ownership of VitalDyne's laser cutting, welding, micromachining and finished device manufacturing capabilities to complement its existing complex catheter shaft design and … [Read more...] about Catheter & Medical Design acquires VitalDyne Medical
CHF Solutions submits patent for peripheral venous access system
CHF Solutions today said it submitted a patent application for a system to dramatically improve and simplify venous access for its Aquadex system. The new system would simplify venous access for Aquadex's ultrafiltration for multiple continuous renal replacement therapy (CRRT) modalities. It is designed to make CRRT therapies available to all … [Read more...] about CHF Solutions submits patent for peripheral venous access system
Biomerics expands Costa Rica, Texas manufacturing operations
Biomerics recently announced that it is doubling its manufacturing footprint in Costa Rica and Texas. The Salt Lake City, Utah-based company broke ground on a new greenfield plant adjacent to its current operations in the La Zeta Free Trade Zone in Cartago, Costa Rica. The new facility totals 110,000 sq. ft and will include engineering labs, … [Read more...] about Biomerics expands Costa Rica, Texas manufacturing operations
Medtronic launches DCB for dialysis patients in Japan
Medtronic (NYSE:MDT) this week said it launched its first drug-coated balloon in Japan for patients undergoing hemodialysis. The company launched its In.Pact AV drug-coated balloon, which is indicated for the treatment of obstructive lesions up to 100 mm in length in the native arteriovenous dialysis fistulae in patients with end-stage renal … [Read more...] about Medtronic launches DCB for dialysis patients in Japan
MedAlliance nabs FDA breakthrough nod for drug-eluting coronary balloon
MedAlliance today said it received FDA breakthrough device designation for its Selution SLR sustained limus release drug-eluting balloon catheter. Selution SLR is designed to treat atherosclerotic lesions in native coronary arteries. The breakthrough designation was awarded for its design of improving luminal diameter in patients with … [Read more...] about MedAlliance nabs FDA breakthrough nod for drug-eluting coronary balloon
LeMaitre Vascular grows 25% in Q4
LeMaitre Vascular yesterday posted fourth-quarter results that beat the consensus forecast on Wall Street. The Burlington, Mass.-based company report profits of $7 million, or 34¢ per share, on sales of $37.5 million for the three months ended Dec. 31, 2020, for a bottom-line gain of 52.5% on sales growth of 24.5% compared with Q4 … [Read more...] about LeMaitre Vascular grows 25% in Q4
The worst catheter-based device recalls of 2020
The U.S. saw nine serious medical device recalls related to catheters in 2020 — up from four the previous year, according to the FDA. The agency 2020 tagged a total of 33 medical device recalls as Class I — the most serious level — down from 49 in 2019. The list of the most serious catheter-based device recalls in 2020 includes products from … [Read more...] about The worst catheter-based device recalls of 2020
Acutus Medical names new chief financial officer
Acutus Medical (Nasdaq: AFIB) today announced that it appointed David Roman as its CFO, effective March 1. Founded in 2011, Carlsbad, Calif.–based Acutus Medical boasts a portfolio of electrophysiology products that includes catheter-based treatments for cardiac arrhythmias. Roman has more than 15 years of experience in the medical technology … [Read more...] about Acutus Medical names new chief financial officer
FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
An FDA advisory panel voted against a favorable recommendation for BD's Lutonix catheter-based, drug-coated balloon for use below the knee. The FDA's Circulatory System Devices Advisory Panel yesterday voted 15-to-2 in favor of the issue of safety when Lutonix is used as intended and voted 15-to-2 against the issue of a reasonable assurance of … [Read more...] about FDA panel votes against BD Lutonix drug-coated balloon for below-the-knee
