AtriCure (NSDQ:ATRC) said yesterday it won FDA 510(k) clearance for its CryoForm cryoablation probe designed for use in cardiac ablation procedures, such as atrial fibrillation. The CryoForm is designed with the ability to remove heat and actively defrost, which allows the operator to safely detach the device while maintaining internal tissue’s frozen state, the West Chester, Ohio-based […]
Cardiovascular
Welcome to MassDevice's Cardiovascular Hub, your resource for the latest news in cardiac implants, structural heart, heart valves, stents and more. Stay informed about the innovations and business news shaping the cardiovascular device industry.
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Cardiac Implants | Structural Heart | Pulsed-Field Ablation
Here are top cardiology features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ LVADs save lives: So why aren’t more available?
+ How Medtronic uses nitinol to improve the structure and effectiveness of heart devices
+ How Abbott designed the world’s first dual-chamber leadless pacemaker system
+ J&J used RWE for expanded indications — and you can, too
+ 7 cardiology startups you need to know
Latest Cardiology News
Study: Patients with Edwards Lifesciences Sapien 3 show higher pacemaker implantation rate
A clinical study of the next-generation Sapien 3 implantable heart valve made by Edwards Lifesciences (NYSE:EW) showed a higher rate of pacemaker implantation than with an earlier version of the device. The study, published online in the journal JACC: Cardiovascular Interventions, compared the 1st 206 patients treated using the Sapien 3 with 371 patients treated with the Sapien XT transcatheter […]
FDA panel to mull St. Jude Medical’s Amplatzer PFO occluder cardiac implant
An FDA advisory panel is slated to review the clinical data behind St. Jude Medical‘s (NYSE:STJ) bid for pre-market approval of its Amplatzer cardiac implant for treating patent foramen ovale. The FDA’s Circulatory System Devices Panel is due to convene May 24 for a hearing on the Amplatzer PFO device, a nitinol and polyester mesh “double […]
Biotronik wins FDA nod for BioMonitor 2
Biotronik said today it won FDA premarket approval for its BioMonitor 2 magnetic resonance imaging-compatible insertable cardiac remote monitor. The BioMonitor 2 device is designed for remote monitoring of patients with atrial fibrillation, syncope, bradycardia and tachychardia, Biotronik said. The device uses Biotronik’s ProMRI technology and is approved for full-body MRI scans at 1.5 and […]
Abbott prevails in 10-year-old stent lawsuit
A 10-year-old whistleblower lawsuit filed by a former Abbott (NYSE:ABT) sales rep, over the alleged off-label marketing of biliary stents, ended yesterday when a Dallas jury found for Abbott. Plaintiff Kevin Colquitt, a former rep for Abbott’s Guidant division, sued Abbott, Johnson & Johnson (NYSE:JNJ) and Boston Scientific (NYSE:BSX) in 2006, claiming that they marketed the use of biliary stents to treat peripheral […]
FDA approves Abiomed’s Impella with indication for cardiogenic shock
Abiomed (NSDQ:ABMD) said today it won expanded FDA premarket approval indications for its Impella line of percutaneous heart pumps to treat patients suffering cardiogenic shock following acute myocardial infarction or cardiac surgery. The Impella devices are now indicated for the stabilization of a patient’s hemodynamics, unloading of the left ventricle, perfusion of the end organs […]
St. Jude Medical launches Trifecta GT valve in Europe
St. Jude Medical (NYSE:STJ) said today that it launched its Trifecta GT aortic valve replacement in the European Union, hailing the device as its most advanced tissue valve. The Trifecta GT won CE Mark approval in the EU in February, the St. Paul, Minn.-based company said. The valve’s titanium stent is covered with tissue to improve tissue-to-tissue […]
ReCor Medical launches trial for Paradise renal denervation device
ReCor Medical said today that it’s enrolled the 1st patients in the 292-patient Radiance-HTN study of its Paradise renal denervation device for treating hypertension. The blinded, randomized and sham-controlled trial is designed to evaluate the Paradise system in patients with essential hypertension taking 2 or fewer medications and patients with treatment-resistant hypertension on a minimum of 3 drugs. The trial […]
FDA clears Medtronic’s miniature Micra transcatheter pacer
Medtronic (NYSE:MDT) said today it won FDA premarket approval for its Micra transcatheter pacing system, which it claims is the world’s smallest pacemaker. The Micra transcatheter pacing system, which at 1/10th the size of a conventional pacemaker is roughly the size of a large vitamin, is designed to be implanted via catheter in the right ventricle […]
Medtronic’s Resolute Integrity tops Abbott’s Xience | ACC 2016 roundup
Medtronic’s Resolute Integrity stent tops Abbott’s Xience in Propel all-comers study Results from the Propel all-comers trial comparing Medtronic‘s (NYSE:MDT) Resolute Integrity drug-eluting stent showed it to be superior to the Xience stent made by rival Abbott (NYSE:ABT). The 1-year study followed 800 patients from the Propel trial who were treated with the Resolute Integrity device, […]
Edwards Lifesciences hits all-time high on Sapien 3 study
Shares in Edwards Lifesciences (NYSE:EW) hit an all-time high yesterday after the company reported strong 1-year data for its Sapien 3 replacement heart valve over the weekend. Results from the Partner II trial from 1,077 intermediate-risk patients showed that the Sapien 3 beat surgical valve replacement across a variety of safety endpoints, Irvine, Calif.-based Edwards said at […]