Edwards Lifesciences reported first-quarter results that exceeded Wall Street expectations after market close today. The maker of catheter-delivered heart implants — including transcatheter aortic valve replacement (TAVR) systems and transcatheter mitral and tricuspid therapies (TMTT) — also increased its full-year sales guidance. EW’s stock price was relatively flat in after-hours trading. Irvine, California–based Edwards Lifesciences […]
Catheters
Integer stock sinks despite Q1 beat as full-year forecast disappoints
Integer stock declined by 10% today despite posting Street-beating first-quarter earnings. Investors were likely reacting to the medtech contract manufacturing giant’s full-year guidance, which was less than the analyst consensus. Plano, Texas–based Integer earned $20.5 million, or 59¢ per share, off of $414.8 million in sales for the quarter ended March 29, 2024. Compared to Q1 […]
Fresenius Medical Care recalls more than 2 million catheter components
The FDA says a recall of Fresenius Medical Care catheter extension sets and luer lock adapters is Class I, the most serious kind. Fresenius Medical Care initiated the recall of a number of its Stay-Safe luer lock adapters and catheter extensions on Jan. 23, 2024. It extends to nearly 2.2 million devices distributed between March […]
Thermedical completes feasibility study to use SERF with PFA
Thermedical announced today that it completed a feasibility study using pulsed field ablation in combination with its SERF ablation system. Weston, Massachusetts–based Thermedical designed its SERF system and Durablate catheter to work with PFA to treat ventricular tachycardia (VT). According to Thermedical, SERF (saline-enhanced radio frequency) ablation provides a new, more efficient form of biological […]
FDA clears computer-assisted thrombectomy system from Penumbra
Penumbra (NYSE:PEN) announced today that it received FDA clearance for and began the launch of its Lightning Flash 2.0 CAVT system. Lightning Flash 2.0 represents the next generation of the company’s computer-assisted vacuum thrombectomy (CAVT) technology. It removes the venous thrombus to treat pulmonary emboli (PE). The system features Lightning Flash algorithms designed for increased […]
10 new, innovative medical devices to watch for in 2024
By Senior Editor Danielle Kirsh and Associate Editor Sean Whooley Significant medical device launches are coming in 2024. Think pulsed field ablation, diabetes treatment tech, surgical robotics and more. Pulsed field ablation news took over at the end of 2023 and the start of 2024, with Medtronic and Boston Scientific garnering significant regulatory approvals. Surgical […]
Boston Scientific has a serious recall involving embolization tech
The FDA announced today that it has designated a Boston Scientific recall of its Obsidio conformable embolic as Class I, its most serious level of recall. The Obsidio embolic is a premixed embolic agent that is delivered in a minimally invasive way through a catheter-based system to block or occlude blood flow to specific blood […]
FastWave Medical wins patent for laser-IVL tech
FastWave Medical announced today that it received a fourth utility patent to strengthen the IP foundation of its IVL platform. Minneapolis-based FastWave develops laser-based intravascular lithotripsy (IVL) technology for treating calcific artery disease. Its platform offers durable and fast energy delivery with enhanced sonic output to navigate complex arterial anatomy through a high-performing catheter. FastWave’s […]
TSSC seeks funding to get fiber optic sensor tech across the finish line
The Shape Sensing Co. is seeking investors to fund the productization and FDA clearance of its fiber optic sensor technology for surgical navigation. Austin, Texas-based TSSC wants to raise $10 million in the Series B round, CEO Ryan DeBoer said in an interview with MassDevice. That should be enough for two-and-a-half years of runway, enough […]
Simpson Interventions wins FDA breakthrough nod for Acolyte image-guided crossing and re-entry catheter
Simpson Interventions announced this week that it received FDA breakthrough designation for its Acolyte image-guided crossing and re-entry catheter system. Campbell, California-based Simpson Interventions designed Acolyte to facilitate the placement and positioning of guidewires and catheters within the coronary vasculature to treat patients with coronary chronic total occlusions (CTOs) who continue to have symptoms after […]
Biosense Webster reports positive dual-energy ablation results
Johnson & Johnson’s Biosense Webster unit today announced positive three-month follow-up results from its SmartfIRE clinical trial. The study evaluated the use of the dual-energy ThermoCool SmartTouch SF catheter. ThermoCool SmartTouch SF is the first dual-energy pulsed field ablation (PFA)/radiofrequency (RF) ablation catheter integrated with a PF and RF ablation index. Biosense Webster’s system in […]