CardioFocus is seeking a PMA supplement with FDA so that it can launch its next-gen HeartLight X3 endoscopic ablation system in the U.S. The move comes more than 10 months after Marlborough, Mass.–based won a CE Mark in Europe for the device, which is used to treat AFib. CardioFocus plans to launch HeartLight X3 in the U.S. immediately after … [Read more...] about CardioFocus seeks PMA supplement to launch HeartLight X3 endoscopic ablation system
Technologies & Devices
Vascular access tech company Velano Vascular raises a total $50m
Velano Vascular announced this month that it closed the second tranche of a $25 million growth financing to bring its total funding to more than $50 million. San Francisco-based Velano develops vascular access technologies designed to enable blood draws from indwelling peripheral IV catheters. The company’s blood collection practice is designed … [Read more...] about Vascular access tech company Velano Vascular raises a total $50m
Bluegrass Vascular touts results of Surfacer catheter trial
Bluegrass Vascular Technologies recently announced positive results from a clinical study of its Surfacer Inside-Out catheter system. The San Antonio-based company said the trial represents the first independent, multicenter study investigating the applicability of the Surfacer system, which is designed to provide access to the jugular vein to … [Read more...] about Bluegrass Vascular touts results of Surfacer catheter trial
IRRAS wins renewed CE mark for IRRAflow catheter
IRRAS this week said it won CE mark approval for its IRRAflow catheter. The new approval comes after the company received two CE marks for its IRRAflow system's tube set with a digital pump and control unit. "We are pleased to receive the final CE mark for IRRAflow in Europe, which is a strategically important geography for IRRAS," president … [Read more...] about IRRAS wins renewed CE mark for IRRAflow catheter
W.L. Gore officials think they can spur insulin delivery system innovation
W.L. Gore announced this week that it is investing in PhysioLogic Devices, a startup developing an implantable intraperitoneal insulin delivery system. The size of the investment was not disclosed. But it was part of Gore's Micro-Equity Investment (MEI) program, which provides investments of up to $500,000. W.L. Gore officials think the … [Read more...] about W.L. Gore officials think they can spur insulin delivery system innovation
FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
The survival rate of right-heart failure patients treated with the Abiomed (NSDQ:ABMD) Impella RP heart pump remained about the same during the latest round of post-approval studies, according to the FDA. That latest rate of survival 30 days post-explant, post-discharge survival or switch to another therapy rate was 72.7%, or 16 out of 22 … [Read more...] about FDA: Abiomed Impella RP survival rate steady when appropriate patients are implanted
LivaNova pulls the plug on transcatheter mitral valve repair device
LivaNova (NSDQ:LIVN) said recently that it is ending its Caisson Interventional transcatheter mitral valve replacement (TMVR) program and plans to restructure its heart valve business to improve profitability. The company’s heart valve business represented nearly $130 million in revenue during fiscal 2018 and saw its revenue numbers decline over … [Read more...] about LivaNova pulls the plug on transcatheter mitral valve repair device
How to develop catheters and minimally invasive surgical devices
Developing innovative catheters and minimally invasive surgical devices is hard. These strategies spur inventive solutions and unlock the path to success. Don Baumgarten, Product Creation Studio Minimally invasive surgery (MIS) offers compelling benefits compared to traditional open surgery, such as faster patient recovery, reduced risk of … [Read more...] about How to develop catheters and minimally invasive surgical devices
Freudenberg expands medical balloon development in Minnesota
Freudenberg Medical said today it has added medical balloon development and balloon rapid-prototyping services to its product development center in Minnetonka, Minn. By establishing a "Balloon Development Center of Excellence," Freudenberg has centralized its balloon development activities to further decrease turnaround times for prototypes … [Read more...] about Freudenberg expands medical balloon development in Minnesota
This new Syneo system combines catheter drilling and cutting processes
Syneo (West Palm Beach, Fla.) recently announced the release of its Accu-Drill DC402C system, which integrates hole drilling with cutting to precision lengths. Accu-Drill DC402C system combines features of Syneo's Accu-Cut 202L and Accu-Drill SD402C. The result, according to Syneo, is less catheter component manufacturing costs, increased … [Read more...] about This new Syneo system combines catheter drilling and cutting processes
