Treatment of serious internal bleeding requires replacing lost blood with fresh donor blood, but this is not always an option. In poor areas and those with a lack of healthcare infrastructure donor blood may simply be unavailable. A new device is being launched by Sisu, a young company based in Baltimore, Maryland, that lets clinicians […]
Tag: Cardiac Surgery
AtriClip FLEX•V Device for Left Atrial Appendage Exclusion Released in U.S.
Atricure has released its new AtriClip FLEX•V Left Atrial Appendage (LAA) Exclusion System in the U.S. following a recent FDA clearance. The device features a trigger release for deploying the clip and an open-ended design in which the tips of the jaws close earlier than the rest of the clip. Some of the features of the AtriClip (Read more...)
HydroPICC Anti-thrombogenic Central Line Catheter Cleared by FDA
Access Vascular, a company based in Bedford, MA that makes a novel material for preventing the clogging up of catheters, won FDA clearance for its HydroPICC catheter. The company’s “bulk-hydrophilic” material is rich in water and carries a neutral surface charge, which helps to prevent proteins and other biomaterials from sticking (Read more...)
SherpaPak and SherpaPerfusion Donor Heart Transport Coolers Cleared in Europe
Paragonix Technologies, based in Braintree, Massachusetts, won European approval to introduce its SherpaPak and SherpaPerfusion cardiac transport systems. The devices are intended for maintaining hearts while they’re being transported from harvest in preparation for transplantation. The SherpaPak device relies on hypothermic static (Read more...)
Edwards Lifesciences’ New CENTERA Transcatheter Aortic Valve Cleared in Europe
Edwards Lifesciences won European approval to introduce its brand new CENTERA transcatheter aortic valve prosthesis. The self-expanding stent comes attached to the delivery instrument, a major improvement over other valves that have to be squeezed, inserted, and attached to the catheter before they can be used. Moreover, a motor-powered handle help (Read more...)
SensOR Medical Allows Surgeons to Feel Again
It’s no secret: minimally invasive surgeries (MIS) are on the rise. The tools used during these advanced scope-based procedures provide little tactile feedback that surgeons used to experience in open surgeries. Working at a distance means it is hard to gauge the force being applied to tissues. The founders at SensOR Medical Laboratories, a m (Read more...)
LivaNova Releases PureFlex Arterial Cannulae in Europe
LivaNova won the European CE Mark of approval and is launching its new PureFlex arterial cannulae for connecting a patient to an extracorporeal support pump. They’re transparent, save for the metal spring that keeps them from kinking. They come in different lengths and sizes, but all interface via standard 3/8″ tips. The tips are availa (Read more...)
Masimo SedLine for Improved Brain Monitoring Under Anesthesia FDA Cleared
Masimo won FDA clearance for its Next Generation SedLine brain function monitoring, a system for assessing the brain while under anesthesia. Next Generation SedLine relies on four EEG (electroencephalography) leads that acquire brain signals from both sides of the brain. The new version of the offering includes an improved signal processing en (Read more...)
Put on Two Surgical Gloves as Fast as One With GAMMEX PI Glove-in-Glove System
Putting on two pairs of gloves is a common occurrence in medicine, particularly among surgeons that work with sharp instruments. It’s frustrating and feels like a waste of time, but that’s reality. Now there are gloves that come already doubled, while being easy to snap on. The GAMMEX PI Glove-in-Glove system from Ansell, a company [&he (Read more...)
Medtronic’s Synchromed II Approved to Pump Remodulin Into Veins to Treat Pulmonary Hypertension
The FDA has issued approval for the Implantable System for Remodulin, which is really the Synchromed II drug infusion system from Medtronic, consisting of an implantable pump, controller, and catheter. The system is used to treat pulmonary arterial hypertension by delivering Remodulin (Treprostinil) into the vein at the superior cava (Read more...)
International Biophysics FloPump 32 Centrifugal Disposable Heart Pump FDA Cleared
International Biophysics, a firm out of Austin, Texas, won FDA clearance for its FloPump 32 centrifugal disposable heart pump. The device is designed to be powered by the Maquet ROTAFLOW console, which can be used as a stand along unit or a part of a heart-lung machine. The new pump won the CE Mark approval in […]
New Replacement Heart Valve Grows as Child Gets Older
Children born with congenital heart valve defects number in the thousands each year, yet there are simply no artificial cardiac valves available that were designed specifically for babies. Multiple heart surgeries have to be performed as the child outgrows successive implants. In addition, since the devices were never intended for children, they of (Read more...)
Surgical Sealants and Beyond: Interview with Christophe Bancel, CEO and Co-Founder of Gecko Biomedical
Medgadget recently reported that Gecko Biomedical, a biomedical start-up based in Paris, France received CE mark approval for their SETALUM Surgical sealant. The bioinspired polymer sealant is cured on-demand using light and can supplement conventional sutures during vascular surgery. The material is biodegradable, bioresorbable, and biocompatible, (Read more...)
3D Printing Helps to Implant Risky Transcatheter Mitral Valves
Transcatheter aortic valve implantations are now routine at a number of high-end hospitals around the world. Minimally invasive mitral valve replacements, on the other hand, are a lot more difficult and prone to post-op complications, and so are still a rarity. Yet, 60% of patients over 75 have mitral valve disease, and it’s an even [… (Read more...)
Stratasys Releases Line of Custom Built 3D Printed Anatomy Models
Stratasys, one of the big 3D printing companies, has announced the release of its new BioMimics line of 3D printed human anatomy models. The products are designed to be used in clinical training and to help design and test new medical devices. The company is first releasing bone and heart models, with vascular structures expected […]
Ultrasound Imaging Needle Set to Transform Heart Surgery
Researchers in London have published details of a revolutionary new cardiology needle capable of imaging the heart’s soft tissues from within. The team from University College London (UCL) and Queen Mary University of London (QMUL) used the new all-optical ultrasound imaging system for heart surgery in pigs, successfully capturing high-resolu (Read more...)
Duke University Heart Patch Shows Promise in Repairing Cardiac Tissue Damage
Researchers at Duke University have developed an artificially-engineered patch consisting of fully functional human heart muscle tissue that can be used to repair damaged areas of the heart. While it’s not the first cardiac tissue to be artificially engineered, it’s significant in that it’s the first that is large enough to be cli (Read more...)
Soft Robotic Cardiac Assist Device for One-sided Heart Failure
Researchers at Boston Children’s Hospital have developed a novel robotic cardiac assist device designed to assist patients with one-sided heart failure. The device combines soft actuators with a rigid brace that penetrates into the heart’s intraventricular septum, to provide gentle but robust pumping assistance to just one side of the h (Read more...)
InterAtrial Shunt Device from Corvia Medical Shows Promising Results in Diastolic Heart Failure
At the recent American Heart Association Scientific Sessions, researchers have announced positive results in a clinical study of the InterAtrial Shunt Device (IASD) from Corvia Medical, which allows blood to travel between the atria of the heart, to safely alleviate the symptoms of diastolic heart failure. Much of the work has been carried out at [ (Read more...)
microMend, a Novel and Time-Saving Wound Closure Device
Sutures and staples are the usual options for closing wounds postoperatively, but they can be painful and require surgical skills. The microMend Skin Closure Device, produced by Seattle-based KitoTech Medical, provides a potentially better alternative. The design of the microMend is conceptually similar to a bandage, like Steri-Strip. The device is (Read more...)