Cardiovascular Systems (NSDQ:CSII) said today that the FDA granted 510(k) clearance to the OrbusNeich‘s 1mm Sapphire II Pro coronary balloon. St. Paul, Minn.-based Cardiovascular Systems touted the newly cleared product as the first and only 1mm coronary balloon available in the US. “Offering the Sapphire II Pro 1.0mm coronary balloon—the smallest, FDA-cleared coronary balloon on the market—is […]
Catheters
FDA clears Access Vascular’s HydroPICC catheter
Access Vascular said today that its HydroPICC catheter has won 510(k) clearance from the FDA. The peripherally-inserted central catheter is designed with Access Vascular’s proprietary bulk-hydrophilic material, which the company touted as “the ideal material for long-term implantable vascular access devices.” “The FDA clearance of the HydroPICC catheter is an important milestone for Access Vascular […]
Abiomed wins expanded Impella FDA nod for elective, urgent high-risk PCI
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5 and Impella CP heart pumps, now cleared for use during elective and urgent high risk percutaneous coronary intervention procedures. With the expansion, the Impella heart pump is cleared for use with patients with severe coronary artery disease, complex anatomy and a number […]
Abiomed touts expanded Impella heart pump indication, launches Women’s Initiative
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval for its Impella 2.5, Impella CP, Impella 5.0 and Impella LD heart pumps, now cleared to provide treatment for heart failure associated with cardiomyopathy leading to cardiogenic shock, including peripartum and postpartum cardiomyopathy. The approval follows a previous FDA indication the Danvers, Mass.-based company won in April […]
J&J’s Cerenovus launches Galaxy G3 mini embolic coil, touts Arise II Embotrap study data
Johnson & Johnson‘s (NYSE:JNJ) Cerenovus division this week announced the launch of its Galaxy G3 Mini embolic coil and released data from a study of its Embotrap device designed to remove clots from the brain following ischemic stroke. The Galaxy G3 Mini coils are designed to be approximately 25% softer than the Galaxy G3 xsft […]
SurModics wins FDA nod for Telemark crossing microcatheter
SurModics (NSDQ:SRDX) said today that it won 510(k) clearance from the FDA for its Telemark 0.014″ coronary and peripheral microcatheter, saying it plans to have the device on the U.S. market “in the coming months.” The Eden Prairie, Minn.-based medical device company said Telemark combines its Xtreme composite shaft technology with its Pristyne hydrophilic coating and […]
Cardiovascular Systems inks partnerships with OrbusNeich, Integer
Cardiovascular Systems (Nasdaq: CSII) announced today that it is expanding its product portfolio through new partnerships with OrbusNeich and Integer. The OrbusNeich partnership makes St. Paul, Minn.–based CSI the exclusive U.S. distributor of Hong Kong–based OrbusNeich‘s balloon products. The deal with Frisco, Texas–based Integer (NYSE: ITGR) involves Integer producing CSI-branded Zilient guidewires. Get the full story on our sister site Medical […]
Abbott launches new ablation catheter in Europe
Abbott‘s (NYSE:ABT) sensor-enabled Advisor HD Grid mapping catheter has won CE Mark approval in the European Union. The device is designed for use in any chamber of the heart during cardiac ablation. Physicians use mapping catheters to identify areas of cardiac tissue that are responsible for sending erratic electrical signals that cause arrhythmias. Abbott touted […]
Guerbet to pay $23.7m for Accurate Medical Therapeutics
Contrast agent-maker Guerbet (EPA:GBT) has inked a €19.5 million ($23.7m USD) deal to acquire Israeli medtech company Accurate Medical Therapeutics. Accurate has developed two series of microcatheters designed for embolization procedures of tumors and vascular aneurysms. The first set of catheters optimize the product’s ability to access hard-to-reach lesions and navigate tortuous vascular networks. The second […]
Edwards Lifesciences recalls Certitude delivery device for Sapien 3 valve
UPDATED Jan. 12, 2018, with comment from Edwards. Edwards Lifesciences (NYSE:EW) is recalling the Certitude delivery device used with its Sapien 3 replacement heart valve on the risk that a molding defect could embolize, the FDA said today. The Sapien 3 is a transcatheter aortic valve replacement designed to treat aortic stenosis. During implantation the valve […]
Cardiovascular Systems escapes revived shareholders suit
Shareholders who revived a purported class-action kickbacks lawsuit against Cardiovascular Systems (NSDQ:CSII) saw their case dismissed with prejudice yesterday by a federal judge in Minnesota. St. Paul, Minn.-based CSI paid $8 million to settle a federal False Claims Act suit in July 2016 accusing it of running a kickbacks scheme by offering free, all-expense-paid training programs, product giveaways, 3rd-party […]