Medtronic (NYSE:MDT) today announced positive findings from a secondary analysis of the PULSED AF study for its pulsed-field ablation technology. The analysis demonstrated positive results for the PulseSelect system, including atrial arrhythmia (AA) burden reduction. This correlated to both improved quality of life and decreased healthcare utilization. Medtronic said in a news release that 87% […]
Cardiovascular
Abbott wins FDA approval for next-gen TactiFlex ablation catheter
Abbott today announced FDA approval of its TactiFlex Ablation Catheter, Sensor Enabled, which the company describes as the world’s first ablation catheter with a flexible tip and contact force technology. The TactiFlex catheter also integrates with Abbott’s EnSite X EP System, enabling physicians to visualize heart anatomy more precisely, according to the company. The result […]
Abbott, Stereotaxis ink robotic surgery partnership
Stereotaxis (NYSE:STXS) announced today that it has entered into a collaboration with Abbott (NYSE:ABT) to take robotic electrophysiology to the next level. The collaboration aims to integrate the Abbott EnSite X EP system — a 3D heart mapping system — with Stereotaxis’ robotic magnetic navigation systems. Bringing the Abbott cardiac mapping system together with Stereotaxis’ […]
FDA approves next-gen MicroPort CRM pacemakers
MicroPort CRM announced today that it received FDA approval for its Alizea and Celea implantable pacemakers. The cardiac rhythm management subsidiary of MicroPort Scientific said its newly approved devices are the longest-lasting pacemakers for their size on the market today. They offer a volume of just 11cc and a projected longevity of 13 years. Additionally, […]
FDA clears insertable cardiac monitor from Abbott
Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM). The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio of connected health devices for managing and treating patients remotely. The device could potentially rival the Medtronic Linq system. […]
J&J’s Biosense Webster gets a new president
Johnson & Johnson’s Biosense Webster this week announced it appointed Jasmina Brooks as president. As president, Brooks will be responsible for setting Biosense Webster’s global strategy and advancing its innovation agenda to position the company for continued growth. Brooks succeeds Michael Bodner, who is now the global head of heart recovery for J&J MedTech. She […]
HeartBeam submits AIMIGo vector ECG for FDA 510(k) clearance
HeartBeam (Nasdaq:BEAT) announced today that it submitted a 510(k) application to the FDA for its AIMIGo system. AIMIGo, a personal, portable vector electrocardiogram (VECG) system assists patients and clinicians in assessing cardiac symptoms. It utilizes a reusable, credit card-sized VECG recording device and cloud-based software. The system can deliver critical data to clinicians in real-time outside […]
Abbott reports positive data for TriClip TEER system
Abbott today announced late-breaking data supporting the benefits of its TriClip transcatheter edge-to-edge repair (TEER) system. The company presented study data at EuroPCR in Paris. This study evaluated TriClip, a first-of-its-kind, minimally invasive device, in treating patients with leaky tricuspid valves. Abbott’s bRIGHT study supported the safety and effectiveness of TriClip in 511 patients with […]
Study backs Edwards aortic valve with Resilia tissue
Edwards Lifesciences (NYSE:EW) today announced new data from a clinical trial evaluating bioprosthetic aortic valves with its Resilia tissue. Data from the COMMENCE aortic trial demonstrated low rates of structural valve deterioration (SVD) in the bioprosthetic valves. It represents the longest clinical follow-up for Edwards’ valve with Resliia tissue at a mean of 7.7 years. […]
Data supports Biosense Webster RF ablation for treating AFib
Johnson & Johnson MedTech’s Biosense Webster today announced data from a study of its QDOT Micro catheter for treating AFib. JACC: Clinical Electrophysiology published data from the Q-FFICIENCY study evaluating QDOT Micro’s safety and 12-month effectiveness. The study observed the use of the catheter in paroxysmal AFib ablation using a combination of high-power and conventional modes. […]
Shockwave Medical launches new coronary IVL catheter
Shockwave Medical (Nasdaq:SWAV) today announced full commercial availability for its C2+ coronary intravascular lithotripsy (IVL) catheter. The company designed its C2+ coronary IVL catheter to treat severely calcified coronary artery disease using pulsatile sonic pressure. Santa Clara, California-based Shockwave, which has been subject to recent acquisition speculation, launched the catheter in select international markets. Shockwave C2+ is […]
