Transseptal Solutions, a firm based in Israel, has been given clearance to introduce its flagship TSP Crosser Transseptal Access System in the U.S. The device is used to provide a path and to deliver catheters into the left atrium of the heart. Most minimally invasive cardiology procedures have been performed on the right side of […]
Tag: Cardiac Surgery
Tiny New Endoscope for Looking Inside Blood Vessels
Cambridge Consultants, a UK firm, and OmniVision, based in California, have developed an impressive intravascular camera. It produces native images at 400 x 400 pixel resolution, considerably better than existing fiber-optic angioscopes, but engineers at Cambridge Consultants believe this can be boosted to 1,600 x 1,600 with its own software techni (Read more...)
Boston Sci’s ACURATE neo2 Aortic Valve Showing High Performance
Boston Scientific is touting results of a clinical study evaluating its ACURATE neo2 prosthetic aortic valve system. The implant and delivery system, which are not yet available for sale, had “a high procedural success rate and a low rate of paravalvular aortic regurgitation,” which is blood leaking around the valve, a month after (Read more...)
GORE Molding & Occlusion Balloon Approved in US, EU, Japan
Gore is releasing its GORE Molding & Occlusion Balloon following regulatory approvals in the U.S., Japan, and Europe. The device is a compliant polyurethane balloon catheter designed for use in opening up self-expanding stent grafts or to temporarily occlude wide vessels. The company believes that the device “meets all endovascu (Read more...)
Two New Advanced Cardiovascular Ultrasounds Debuted by Philips
Philips is releasing two new cardiovascular ultrasound systems that feature similar capabilities, but one is designed for the office while the other is geared for the cath lab. The company says that the new systems have improved image quality and a variety of features that improve usability. The EPIQ CVx, intended for the office, lets […]
Flow Diverter with Hemodynamic Sensor to Monitor Aneurysm Treatment
Flow diverters are implants that are commonly used to prevent blood from flowing into aneurysms. They look very similar to stents, and are often combined into one device, but instead of providing structural strength, they provide a way for blood to pass from one part of a vessel to another without flowing into a bulging […]
Implantable System for Remodulin FDA Approved to Treat Pulmonary Hypertension
Medtronic won FDA approval for its Implantable System for Remodulin (ISR) as a new treatment option for people with pulmonary arterial hypertension. It consists of Medtronic’s Synchromed II drug delivery system, an intravascular catheter, and United Therapeutics‘ Remodulin (treprostinil) Injection medication. Unlike external i (Read more...)
“Ticker” by Mimi Swartz: A Medgadget Book Review and Interview with the Author
Of all the organs in the human body, the heart is arguably the most important, well-known, and worried about. Not only is the heart the vital electro-mechanical pump that moves about 2,000 gallons of our blood every day, but for centuries it’s been symbolic of the seat of emotion, reason, and life itself for many […]
Medtronic’s HVAD Heart Pump FDA Approved for Less Invasive Implantation
Medtronic’s HVAD System, a left ventricular assist device, can now be implanted via a thoracotomy, a less invasive procedure than a median sternotomy. Moreover, a thoracotomy means that future procedures that may require access through the chest can still be performed in what are already risky patients. The HVAD System is indicated (Read more...)
Simulation Software Helps to Repair Diseased Heart Valves
At this week’s Computer Assisted Radiology and Surgery conference (CARS 2018) in Berlin, scientists from the Fraunhofer Institute for Medical Image Computing in Germany will be showing off their unique software that helps to fix cardiac valves. Designed for minimally invasive procedures, which involve placing special rings that correct n (Read more...)
Exclusive Tour of Materialise, a Leader in 3D Printing of Patient Specific Parts
3D printing technology was originally touted to provide consumers the ability to print customized mugs, plates, and other household items. The reality turned out to be a lot more exciting, at least for us in the medical space, since 3D printing is already being used daily by thousands of doctors to help perform procedures that […]
New Transcatheter Aortic Heart Valve to Treat Regurgitation and Stenosis
JC Medical, based in Burlingame, California, has announced that its J-Valve transfemoral transcatheter aortic valve system has been implanted in the first patient to treat aortic regurgitation. Other transcatheter aortic valves available in the U.S. are indicated for aortic stenosis only, but the new device hopes to also treat pure aortic regurgita (Read more...)
3D Printing Cardiac Components for Pediatric Patients: Interview with Prof. Michael Davis, Georgia Tech
Congenital heart disease is the most common birth defect globally, affecting almost nine in every 1,000 babies. Tissue engineering, which involves combining regenerative cells, proteins, or drugs with biomaterials, is a promising strategy to treat congenital heart diseases. A particularly exciting development is the use of 3D printers to fabricate (Read more...)
IQcool Warm System FDA Cleared to Cool and Rewarm Patients
BrainCool, a Swedish company, obtained FDA clearance for its IQool Warm System. The device, the name of which seems to be intended to be an oxymoron, can be used to both cool and reheat patients. The company’s first FDA cleared product, the IQool, which looks identical to the newly approved one, is indicated for rapidly […]
FDA Clears FlowTriever, First Device to Pull Blood Clots from Lungs
Inari Medical of Irvine, California won the first FDA clearance for a thrombectomy device to be used for treatment of pulmonary embolisms. The FlowTriever went through a clinical study involving 106 patients with acute pulmonary embolism and RV/LV (right ventricular/left ventricular) ratio of at least 0.9 that were treated using the device ins (Read more...)
Computer Simulations Help Grow Custom Replacement Cultured Heart Valves
Prosthetic heart valve implantations have become common in modern hospitals, but these devices are still far from perfect. Issues with longevity, calcification, and maintenance of a good fit over many years following placement are some of the existing concerns. An entirely different approach, which involves growing new valves from cultured human ce (Read more...)
Terumo Releases a Narrower Stent-Graft for TEVAR Procedures
Terumo is launching in Europe its RelayPro Thoracic Stent-Graft System, initially being released to a limited set of institutions with wider availability expected soon. The device is designed to allow patients with narrower access vessels to benefit from thoracic endovascular aortic repair (TEVAR) procedures. It’s based on the previously (Read more...)
TransMedics’ Lung Preservation System Approved in U.S. for Double Transplants
TransMedica, based in Andover, Massachusetts, won FDA approval to introduce its Organ Care System (OCS) LUNG for use in standard double lung transplant procedures. The approval was based on the INSPIRE Trial, which the company touts as being the largest lung preservation for transplantation trial ever. Twenty one institutions around the world (Read more...)
Interview with Tal Golesworthy, Inventor of the ExoVasc Aortic Root Support
Tal Golesworthy is the inventor of the ExoVasc, a bespoke implant that supports the aortic root when it has becomes weak and dilated. Tal’s invention was born out of his personal need for the device to support his aorta that was expanding dangerously due to Marfan syndrome. In 2004, Tal was the first patient to […]
GORE CARDIOFORM Septal Occluder Approved by FDA for PFO Closure
The FDA has approved the GORE CARDIOFORM Septal Occluder for patent foramen ovale (PFO) closure procedures that have shown to reduce the chance of stroke in some patients. The CARDIOFORM is already being used in the U.S. for closing of atrial septal defects up to 17 millimeters in size. The catheter-delivered device consists of two […]