The FDA has deemed the recall of the Medtronic (NYSE:MDT) Valiant Navion thoracic stent-graft system as Class I, the most serious kind. Medtronic's Valiant Navion is designed to repair lesions of the descending thoracic aorta. It uses a long catheter to place the stent graft inside the aorta. The stent graft expands to fit within the aorta to … [Read more...] about Medtronic stent graft recall is serious
Abbott Xience stent gains expanded CE mark
Abbott (NYSE:ABT) announced today that its Xience stent received CE mark approval for a shorter duration of dual anti-platelet therapy (DAPT). The European approval for the stent allows for the DAPT to go as short as 28 days, the shortest indication available in the world for patients with high bleeding risk (HBR), according to a news … [Read more...] about Abbott Xience stent gains expanded CE mark
Erbe Elektromedizin to acquire Maxer Endoscopy
Erbe Elektromedizin announced today that it is set to acquire Maxer Endoscopy for an undisclosed amount. Teubingen, Germany–based Erbe Elektromedizin develops, manufactures and distributes surgical instruments and devices in almost all specialist areas. Combined with other Erbe technologies, the surgical instruments are based on … [Read more...] about Erbe Elektromedizin to acquire Maxer Endoscopy
SoniVie wins FDA breakthrough nod for renal denervation tech
SoniVie announced that it received FDA breakthrough device designation for its Tivus renal artery denervation technology. Tivus (therapeutic intra-vascular ultrasound system) is designed for treating resistant hypertension through renal artery denervation. The system previously received breakthrough designation for treating pulmonary arterial … [Read more...] about SoniVie wins FDA breakthrough nod for renal denervation tech
Micro-Tech Endoscopy launches new dilation balloon
Micro-Tech Endoscopy USA announced that it launched its new ABC Balloon for esophageal, pyloric or colonic dilation. Ann Arbor, Mich.-based Micro-Tech's new balloon expands its current line of products, with six available diameter size, all with a balloon length of 5.5 cm, according to a news release. Micro-Tech said in the release that its … [Read more...] about Micro-Tech Endoscopy launches new dilation balloon
Boston Scientific CEO Mike Mahoney talks Lotus decision, post-COVID outlook
Boston Scientific (NYSE:BSX) made waves this month when it recalled and retired its Lotus TAVR product line. Subsequent layoffs, first in Minnesota, then in Ireland, highlighted the impact of the decision to pull Lotus from the highly competitive market as a result of complexities related to the product delivery system and solely that — as the … [Read more...] about Boston Scientific CEO Mike Mahoney talks Lotus decision, post-COVID outlook
CHF Solutions seeks patent for new Aquadex SmartFlow tech
CHF Solutions (NSDQ:CHFS) announced today that it submitted a patent application for a new advance to its Aquadex SmartFlow system. Eden Prairie, Minn.-based CHF Solutions develops Aquadex SmartFlow consoles for removing excess fluid from patients suffering from hypervolemia (fluid overload), which have recently been in demand due to … [Read more...] about CHF Solutions seeks patent for new Aquadex SmartFlow tech
Philips touts post-stent imaging study results
Royal Philips (NYSE:PHG) announced today that one-year results of its Define PCI study that reported improved outcomes and less recurrent angina. The Define PCI study assessed the level of residual ischemia found in patients following a percutaneous coronary intervention (PCI) using a blinded instant wave-free ratio (iFR) pullback measurement, … [Read more...] about Philips touts post-stent imaging study results
NanoVibronix device gains FDA nod for import to U.S.
NanoVibronix (NSDQ:NAOV) announced that it received FDA enforcement discretion for the U.S. distribution of the UroShield device. According to a news release, the FDA exercised its enforcement discretion, giving Elmsford, N.Y.-based NanoVibronix’s UroShield an intended use code (IUC), clearing the way for the import of the system to the U.S. … [Read more...] about NanoVibronix device gains FDA nod for import to U.S.
Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
Boston Scientific (NYSE:BSX) said it is recalling specific lots/batches of its Hurricane RX biliary balloon dilation catheters. Marlborough, Mass.-based Boston Scientific, which issued a warning letter from its international location in France, said the removal comes in response to an increase in complaints of the RX tunnel component (black … [Read more...] about Boston Scientific warns on Hurricane RX biliary balloon dilatation catheter
