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 infusion pumps, the Implantable System for Remodulin is completely implantable, reducing infection risk and […]
Tag: Cardiac Surgery
“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 for those with advanced, refractory heart […]
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 native valve anatomy, the software helps to […]
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 regurgitation and a combination […]
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 custom cardiac components to replace […]
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 instead of commonly used […]
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 cells, may overcome many […]
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 available RelayPlus, but with an outer diameter […]
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 were involved comparing the […]
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 […]
Ferromagnetic FMsealer Laparoscopic Shears for Faster Vessel Sealing with Fewer Side Effects
Domain Surgical out of Salt Lake City, UT, which is part of OmniGuide, itself based in Lexington, MA, is releasing new laparoscopic shears based on its ferromagnetic technology. The FMsealer Laparoscopic Shears, unlike bipolar electric devices, do not release electric current into the tissues when transecting and sealing. And unlike ultrasonic shears, a lot less heat […]
Convesaid, a Hemostat Powder Spray That Can’t Cause Embolisms
Team Consulting, a firm based out of an old barn in Cambridge, UK that develops medical devices, one being the EpiPen, has now come up with a hemostat powder sprayer that cannot cause embolisms. When spraying a powder onto a leaking vein, the air that pushes the powder can enter the exposed blood flow and […]
New Canon Aplio i900 Cardiovascular Ultrasound Unveiled
At the American College of Cardiology 2018 annual meeting, Canon has unveiled the latest version of its Aplio i900 cardiovascular ultrasound system that can be used for advanced cases such as transcatheter implantation procedures. The system features a number of 4D capabilities such as 4D TEE transcatheter procedure guidance, as well as MVA (Mitral Valve Analysis), which helps to […]
Oregon Health & Science University’s Artificial Heart Ready for Animal Trials
Researchers at the Oregon Health & Science University (OHSU) are developing an artificial heart that may one day serve as a long-term replacement for failing natural hearts. This would be a major development, as the only FDA approved artificial heart, the SynCardia temporary Total Artificial Heart , is only meant as a “bridge” to a transplant. OHSU’s device […]
FDA Approves Smallest Heart Valve: Small Enough for Newborns
The world’s smallest prosthetic heart valve has been approved by the FDA, allowing even newborns to benefit from a replacement that was designed to match their anatomy. The Masters HP 15mm rotatable mechanical heart valve can be used to replace either mitral or aortic valves that are not good candidates for repair procedures. The valve is now […]
Patient Aortas Printed in 3D to Test How Replacement Valves Will Work
Implanting prosthetic heart valves is a challenge requiring careful matching of the implanted device to the patient anatomy, as well as placing the implant so that there are no leaks, hemodynamic occlusions, nor a configuration that promotes clot formation. While this is relatively manageable when performing open heart valve replacements, using transcatheter valves is a […]