Transit Scientific this week announced that it has received FDA clearance for its hydrophilic-coated XO Cross microcatheters for guidewire support, exchange and contrast media injection in the peripheral vasculature. The 510(k) clearance includes new 2Fr XO Cross 14 microcatheters, 2.6Fr XO Cross 18 microcatheters and 3.8Fr XO Cross 35 support … [Read more...] about FDA clears XO Cross microcatheters
Catheters
Argon Medical launches portal vein access devices
Argon Medical Devices today announced that it has launched two unique portal vein access sets for transjugular access in diagnostic and interventional procedures. Frisco, Texas-based Argon designed its Scorpion portal vein access series to address the challenge of placing a transjugular intrahepatic portosystemic shunt. The series includes the … [Read more...] about Argon Medical launches portal vein access devices
Boston Scientific recalls Hurricane RX biliary balloon dilation catheters
Boston Scientific has issued a warning letter recalling some of its Hurricane RX biliary balloon dilation catheters. Marlborough, Massachusetts-based Boston Scientific issued the recall because of complaints received for pinholes in the balloon. The balloon could rapidly lose pressure or fail to maintain pressure due to the issue. The recall … [Read more...] about Boston Scientific recalls Hurricane RX biliary balloon dilation catheters
Medtronic faces longer road to renal denervation
Medtronic (NYSE:MDT) will continue the clinical study of its Symplicity Spyral renal denervation (RDN) system for hypertension into next year after lacking the positive results needed to end enrollment early. Fridley, Minnesota-based Medtronic said last month that it hoped to present results of the Spyral HTN-ON MED trial at the Cardiovascular … [Read more...] about Medtronic faces longer road to renal denervation
Study finds single-use bronchoscopes reduce hospital readmission rates by half
A study of 14,228 bronchoscopy procedures found sterile, disposable scopes reduced readmission rates by more than half. The study, authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities. He found that 3.6 percent of patients treated with a single-use, flexible … [Read more...] about Study finds single-use bronchoscopes reduce hospital readmission rates by half
OmniVision launches cable modules for single-use endoscopes, catheters
OmniVision Technologies today announced that it has launched its OVMed OCHSA and OCHTA cable modules for single-use endoscopes and catheters. The Santa Clara, California-based company designed the medical-grade imaging subsystems with a small diameter camera module that is fully integrated with OVMed cables and mini-LED … [Read more...] about OmniVision launches cable modules for single-use endoscopes, catheters
Cook Medical issues voluntary recall for transseptal needles, transseptal needles with catheter
Cook Medical this week announced a global voluntary recall of its Transseptal Needle and Transseptal Needle with catheter. Bloomington, Indiana-based Cook Medical issued the recall due to complaints of rust on the products. The use of both products could result in increased procedural time and inflammatory reactions, including systemic reactions … [Read more...] about Cook Medical issues voluntary recall for transseptal needles, transseptal needles with catheter
Stereotaxis touts positive results in robotic cardiac ablation study
Stereotaxis this week announced positive outcomes of an independent study assessing its robotic cardiac ablation system in pediatric patients. The St. Louis-based company's robotic technology demonstrated superior safety and efficacy in treating atrioventricular reentry tachycardia (AVRT) and atrioventricular nodal reentry tachycardia (AVNRT) in … [Read more...] about Stereotaxis touts positive results in robotic cardiac ablation study
OneProjects raises $17M to advance 4D cardiac imaging
Irish-German cardiac imaging startup OneProjects today announced $8 million in Series A2 funding and two grants totaling $9 million. The company will use the new funds to complete product development, conduct clinical trials, gain FDA clearance and prepare for U.S. commercialization of the first product developed from its proprietary 4D cardiac … [Read more...] about OneProjects raises $17M to advance 4D cardiac imaging
Cook Medical warns on some Flexor Check-Flo introducer sheaths
Cook Medical recently issued a warning letter regarding an issue with its Flexor Check-Flo introducer catheters. Bloomington, Indiana-based Cook Medical's field safety corrective action informs users that some of its introducer sheaths may be manufactured incorrectly and that the radiopaque marker band may be located just below the Check-Flo … [Read more...] about Cook Medical warns on some Flexor Check-Flo introducer sheaths