ZOLL Medical, a part of the Asahi Kasei Group, won EU clearance for its SuperSaturated Oxygen (SSO2) Therapy System to be used to minimize the damage that heart attacks cause within heart muscle. Approved about a year ago in the United States, SSO2 is the only option beyond percutaneous coronary intervention (stenting) that can help […]
Tag: Cardiac Surgery
Electric Stimulation Gives Robot-Assistive Surgery a Sense of Touch
A team of researchers at Texas A&M have performed studies evaluating how electrical stimulation can help users control robots, for example helping surgeons steady their movements during robot-assisted procedures. They found, in 11 subjects, that small electrical stimulations to the fingertips can help users control the pinching of a hardwood bl (Read more...)
Abbott TriClip Cleared in Europe for Minimally Invasive Tricuspid Valve Repair
Abbott announced that it received the European CE Mark for its TriClip Transcatheter Tricuspid Valve Repair System, a minimally-invasive device for tricuspid regurgitation repair. Like many other valve repair devices, TriClip is designed for implantation using a minimally-invasive transcatheter procedure. Unlike other devices, however, TriClip work (Read more...)
Optimizer System for Cardiac Contractility Modulation: Interview with Dr. Ishu Rao, Medical Director of Impulse Dynamics
Impulse Dynamics, based in Mt. Laurel, New Jersey, has developed the Optimizer system, a device designed to improve myocardial contractility in patients with heart failure. The system is intended to improve the quality of life of heart failure patients by reducing the severity of their symptoms. At present, many heart failure patients have few opti (Read more...)
Next-Gen TherOx SuperSaturated Oxygen Delivery System FDA Approved
ZOLL Medical, now a part of Asahi Kasei Group, won FDA approval for the latest version of its TherOx System. The product is designed to deliver SuperSaturated Oxygen (SSO2) therapy to limit heart muscle loss following “widowmaker” heart attacks, aka left anterior descending ST-elevation myocardial infarction (LAD STEMI) chronic total ob (Read more...)
Respirix for Non-Invasive Cardiopulmonary Monitoring: Interview with CEO Eric Kriegstein
For patients with cardiopulmonary illnesses such as chronic obstructive pulmonary disease (COPD or congestive heart failure (CHF), few technologies exist to effectively monitor and manage their conditions in a convenient way. Pulmonary artery catheters and implants, that can help with monitoring, have successfully reduced heart failure hospitalizat (Read more...)
Universal Biomedical 3D Printing Ink Developed
3D printing is already used in medicine in many applications, but there’s still a great deal that custom-built implants could offer to patients. Bioinks, the materials from which bespoke implants can printed, may be the most important focus of research aimed at expanding the use of additive manufacturing, another term for 3D printing, in medi (Read more...)
TriGUARD 3 Wins CE Mark for Cerebral Protection During Transcatheter Heart Procedures
Keystone Heart Ltd. announced that is has received the European CE Mark for its TriGUARD 3, a device designed to minimize the risk of cerebral damage by deflecting embolic debris away from cerebral circulation during transcatheter aortic valve implantation and other transcatheter heart procedures. According to the announcement, the TriGUARD&nb (Read more...)
Stereotaxis Genesis Robotic Magnetic Navigation System Cleared in U.S.
Stereotaxis, with offices in St. Louis, MO and the Netherlands, has won FDA clearance for the Genesis RMN System, a new generation of the company’s robotic navigation systems for the delivery of magnetic ablation catheters to address cardiac arrhythmias. The system can access all chambers of the heart and coronary vasculature, and can also be (Read more...)
ProtEmbo for Reducing Strokes Caused by TAVR Procedures: Interview with Founders
During transcatheter aortic valve replacements (TAVR), there is a risk of cerebrovascular events due to embolic debris breaking off from vessel walls and migrating to the brain. While microembolization during the procedure is a universal phenomenon, the majority of patients experience no symptoms. However, a clinically-evident stroke is a serious a (Read more...)
V-Wave Shunt for Relief of Heart Failure Symptoms Cleared in EU
Heart failure patients often suffer from high pressure within the left side of their hearts, which can lead to difficulties breathing and other debilitating conditions. V-Wave, an Israeli firm, won the European CE Mark of approval for its Ventura interatrial shunt that aims to regulate left atrial pressure by creating a passage for blood to [&helli (Read more...)
Abbott’s FlexNav Cleared in EU to Deliver Portico Transcatheter Aortic Valve
Abbott announced that it received the EU CE Mark for the new FlexNav delivery system for the company’s Portico transcatheter aortic valve. Transcatheter aortic valve replacement (TAVR) is a minimally invasive procedure for patients diagnosed with aortic stenosis, a condition which restricts blood flow through the valve. TAVR is particularly i (Read more...)
CryoLife Wins EU CE Mark for E-vita Open NEO Hybrid Stent Graft
CryoLife, Inc., a company based outside of Atlanta, Georgia, announced this week that it has received the European CE Mark for the E-vita Open NEO, a hybrid stent graft system for the treatment of aortic arch disease. Aortic arch disease encompasses both aortic aneurysms and aortic dissections, which occur suddenly and could be fatal. Ac (Read more...)
Jewel Wearable Cardioverter Defibrillator Could Help Prevent Sudden Cardiac Deaths
In the United States sudden cardiac death (SCD) claims 325,000 lives every year. SCDs are due to abnormalities in the conducting system of the cardiac tissue, resulting in arrhythmias, and can often occur after cardiac surgeries and other treatments. SCDs are medical emergencies, as cardiopulmonary resuscitation and defibrillation must be administe (Read more...)
Cardiovalve Wins FDA Breakthrough Device Designation for Transcatheter Tricuspid Valve Replacement System
Cardiovalve announced that it received FDA Breakthrough Device Designation for its Transcatheter Tricuspid Valve Replacement System. The company also received approval for an Early Feasibility Study of the device for tricuspid and mitral valve regurgitation indications. The Cardiovalve transcatheter system is designed for treatment of mitral a (Read more...)
nView Medical’s Fast 3D Intraoperative Imaging with Less Radiation: Interview with CEO Cristian Atria
Fluoroscopy is used in surgical procedures to visualize structures and tools in real-time, allowing surgeons to monitor the movement of a device, instrument, or body part. However, fluoroscopy is a 2D technology that can lead to surgical inaccuracies. Alternative 3D imaging systems provide higher accuracy, but they sometimes require pausing the sur (Read more...)
Artificial Self-Assembled Blood Vessels
A team of researchers headed by groups at University of Nottingham and Queen Mary University London have come up with a smart material that forms into new blood vessels. Made out of graphene oxide and a protein, the material is 3D printed and naturally forms into tubular shapes that are very similar to blood vessels. […]
On-X Ascending Aortic Prosthesis Cleared in EU
CryoLife, based in Kennesaw, Georgia, won EU regulatory clearance for the On-X Ascending Aortic Prosthesis (AAP) as a treatment option for people with poorly functioning aortic valves with a nearby ascending aortic aneurysm. The device, which combines a prosthetic valve and an ascending aortic prosthesis, can be implanted to address injured, damage (Read more...)
New HydroPICC Prevents Clogged Central Line Catheters
Access Vascular, based in Bedford, Massachusetts, won FDA clearance for the latest version of its HydroPICC anti-thrombogenic central line catheter. As with the original, which was cleared two years ago, the new device features Access’s unique “bulk-hydrophilic” material that prevents clogging by being rich in water while carrying (Read more...)
Adjustable Heart Valves Grow with Kids Hearts
A variety of congenital cardiac abnormalities require the placement of prosthetic heart valves in very young children. As the hearts grow, the valves have to be replaced through repeated surgeries. A team of researchers from Harvard and Boston Children’s Hospital have now developed an artificial valve that can be expanded, via a minimally inv (Read more...)