Cordis recently issued a warning letter regarding an issue with its Smart Flex vascular stent system. Santa Clara, California-based Cordis's field safety correction action informs users that some of its Smart Flex vascular stents have the potential for distal tip dislodgment or separation due to inadequate adhesive application. The recall … [Read more...] about Cordis recalls some Smart Flex vascular stent systems
Pentax Medical expands Vizient contract to include pediatric endoscopes
Pentax Medical today announced it has expanded its contract with Vizient to include pediatric endoscopes. The contract will give Pentax Medical the ability to offer endoscopes to Vizient member hospitals through the Vizient Pediatric Program. The agreement also includes other value-added offerings, education opportunities and best … [Read more...] about Pentax Medical expands Vizient contract to include pediatric endoscopes
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
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
Potrero Medical appoints medtech vet Steve Okland as chief commercial officer
Potrero Medical today announced that it has appointed Steve Okland as chief commercial officer. Prior to joining the sensory integrated foley catheter company, Okland has served on the leadership teams at Second Sight Medical and DryShield. He has also held sales and marketing leadership roles at Miramar Labs, Medivance, Spectranetics and Boston … [Read more...] about Potrero Medical appoints medtech vet Steve Okland as chief commercial officer
Boston Scientific announces positive data for Eluvia stent
Boston Scientific this week announced positive data for its Eluvia drug-eluting vascular stent system. Data presented this week included one-year results from the company's Eminent trial, which showed superiority of the Eluvia stent compared to self-expanding bare metal stents (BMS) to treat patients with peripheral artery disease (PAD) and … [Read more...] about Boston Scientific announces positive data for Eluvia stent
FDA clears expanded indications for BD’s Rotarex atherectomy system
BD this week announced that it has received FDA 510(k) clearance for expanded indications for its Rotarex atherectomy system. Franklin Lakes, N.J.-based BD designed the Rotarex as a rotational excision device that removes and aspirates varying lesion morphologies in the peripheral arteries. "The Rotarex atherectomy system is quick and … [Read more...] about FDA clears expanded indications for BD’s Rotarex atherectomy system
Ambu secures CE mark for single-use bronchoscope and sampling system
Ambu recently announced that its single-use bronchoscope and specimen sampling system won CE mark approval. Ambu's aScope 4 Broncho sampler set is a sterile, single-use device for bronchial wash and bronchoalveolar lavage procedures. "Ambu's combined system simplifies the sampling process with fewer steps from plan to procedure to completion. … [Read more...] about Ambu secures CE mark for single-use bronchoscope and sampling system
Medtronic wins CE mark approval for radial artery access portfolio
Medtronic today said it has received CE mark approval for its radial artery access portfolio. The radial artery access devices include the Rist 079 radial access guide catheter and the Rist radial access selective catheter. Medtronic designed the Rist 079 guide catheter to access the neuro vasculature through the radial artery instead of … [Read more...] about Medtronic wins CE mark approval for radial artery access portfolio
FDA approves Abbott’s next-gen Epic Plus heart valves
Abbott (NYSE:ABT) announced today that it received FDA approval for its Epic Plus and Epic Plus Supra stented tissue valves. The approval offers improved therapy options for people with aortic or mitral valve disease through the next-generation devices that build off of Abbott’s Epic surgical valve platform, according to a news release. Get the … [Read more...] about FDA approves Abbott’s next-gen Epic Plus heart valves
