Abiomed (NSDQ:ABMD) announced today that it received FDA investigational device exemption approval to begin a clinical trial for the Impella ECP heart pump. Impella ECP (expendable cardiac power) will be studied in the early feasibility, first-in-human trial for high-risk percutaneous coronary intervention (PCI) patients, according to a news release. The prospective, multi-center, non-randomized trial will assess […]
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
Survey: Half of heart attack patients avoid the hospital during pandemic
The number of heart attack patients seeking urgent hospital care has dropped by more than 50% worldwide during the COVID-19 outbreak, according to a survey by the European Society of Cardiology (ESC). The survey of 3,101 healthcare professionals in 141 countries was conducted in mid-April.The findings are published in European Heart Journal — Quality of Care and […]
Abbott issues urgent field safety notice over ablation catheter
Abbott (NYSE:ABT) has issued an urgent field safety notice to notify users of complaints about the TactiCath quartz contact force ablation catheter. The notice out of Germany, dated May 28, warns on complaints regarding a loss of contact force information while using the TactiCath product. This issue could cause ineffective ablation that could lead to atrial […]
FDA says lay rescuers can use Zoll AED 3 defibrillator
Zoll Medical announced yesterday that its Zoll AED 3 defibrillator received FDA premarket approval (PMA) for use by lay rescuers. Chelmsford, Mass.-based Zoll’s AED 3 defibrillator uses CPR technology with integrated, real-time feedback to deliver guideline-compliant CPR to improve outcomes from sudden cardiac arrest. The company touts its enhanced technology as the first in the […]
Gallup has a new poll that medtech should care about
Fewer Americans are worried about going to the doctor amid the COVID-19 pandemic, according to a new online poll from Gallup. The poll provides good news for the medical device industry as it seeks to recover from a dropoff in elective procedures — and even procedures that people need — as hospitals focus on treating […]
Boston Scientific launches DirectSense technology
Boston Scientific (NYSE:BSX) announced today that it launched its DirectSense for monitoring the effect of radiofrequency (RF) energy during cardiac ablation procedures. Marlborough, Mass.-based Boston Scientific’s DirectSense is available on the Rhythmia HDx mapping system that won FDA approval in April. Rhythmia HDx monitors changes in local impedance — electrical resistance — around the tip of […]
FDA issues EUA for Abiomed Impella RP to treat COVID-19 heart failure
Abiomed (NSDQ:ABMD) announced that it received FDA emergency use authorization (EUA) for its Impella RP for use with COVID-19-related right heart failure. The Impella RP temporary heart pump provides circulatory support for patients with right side ventricular failure. It won FDA approval in September 2017 for such an indication and in October 2019 Abiomed reported real-world data […]
Acutus Medical, Biotronik ink deal
Acutus Medical and Biotronik have announced that they will collaborate on electrophysiology, mapping, ablation and accessory products across certain markets. The products involved in the collaboration center around the treatment of cardiac arrhythmias in markets that include Europe and Asia, according to a news release. The partnership centers on Acutus’ AcQMap system, which Acutus touts […]
Four deaths linked to Medtronic HeartWare recall
FDA has designated a Medtronic (NYSE:MDT) recall of its HeartWare HVAD Pump Outflow Graft and Outflow Graft Strain Relief as Class I — its most serious level. Medtronic, according to FDA, said the outflow graft of the HVAD Pump could tear and the strain relief screw may break during assembly prior to implant, but might not be […]
LivaNova touts results of sutureless aortic valve study
LivaNova (NSDQ:LIVN) said today that its Perceval sutureless implant is safe and effective compared to standard aortic valve replacement, according to a clinical study. The study, presented at the 100th annual meeting of the American Association of Thoracic Surgery (AATS), revealed that the Perceval sutureless surgical aortic valve demonstrated freedom from major adverse cerebral and cardiovascular […]
Biotronik touts results of CRT-DX study
Biotronik today touted results confirming that its two-lead CRT-DX system provides equivalent therapy compared to conventional three-lead systems. The CRT-DX systems include a CRT-DX pulse generator and a DX implantable cardioverter-defibrillator (ICD) lead to provide atrial sensing and help reduce complications associated with an additional atrial lead for patients who do not need atrial pacing. […]