The U.S. Food and Drug Administration (FDA) issued a letter Jan. 17, 2019, to healthcare providers regarding a recent publication that suggests a possible increased risk of death at two years and beyond in patients treated for a type of peripheral artery disease (PAD) with paclitaxel-coated balloons or paclitaxel-eluting stents. The letter was issued in response to a recent publication in the Journal of the American Heart Association identifying the risk. It recommends doctors continue to monitor these patients, and discuss the benefits and risks of all available treatment options for patients with PAD.

Artificial Intelligence in medical imaging was the top trend and buzz at RSNA 2018.

Artificial intelligence (AI) was by far the hottest trend discussed in sessions and across the expo floor at the world's largest radiology conference, the 2018 Radiological Society Of North America (RSNA). At the meeting in late November, there was an explosion of AI and deep learning algorithms across the expo floor. How machine learning will impact medical imaging was the key takeaway from the opening session, where examples of how AI will alter medical imaging in the near future were highlighted.

Philips announced that NewYork-Presbyterian Hospital has chosen to implement the company’s IntelliSpace Enterprise Edition solution across its hospitals and facilities. In a 10-year agreement, IntelliSpace Enterprise Edition will provide the health system with access to Philips’ full suite of informatics solutions across radiology, cardiology and analytics to help improve efficiencies and care delivery.

Society for Cardiovascular Magnetic Resonance (SCMR) 22nd Annual Scientific Sessions

Cerenovus, of Johnson & Johnson Medical Devices Companies, recently launched the EXCELLENT Registry to collect and analyze stroke-inducing blood clots removed from the brain with its Embotrap II Revascularization Device. The company also announced European CE Mark approval for the Geometric Clot Extractor (GCE) Revascularization Device.

Shockwave Medical Inc. has initiated its U.S. Food and Drug Administration (FDA) Investigational Device Exemption (IDE) study – DISRUPT CAD III – for the use of intravascular lithotripsy (IVL) in heavily calcified coronary arteries. IVL is a lesion preparation tool designed to fracture problematic calcium using sonic pressure waves in order to facilitate stent delivery, deployment and expansion.

Abbott announced the U.S. Food and Drug Administration (FDA) approved the Amplatzer Piccolo Occluder to treat patent ductus arteriosus (PDA). The company calls it the world's first medical device that can be implanted in the tiniest babies (weighing as little as two pounds) using a minimally invasive procedure to treat PDA. The Amplatzer Piccolo, a device even smaller than a small pea, now offers hope to premature infants and newborns who need corrective treatment, and who may be non-responsive to medical management and high risk to undergo corrective surgery.

Boston Scientific Corp. and Edwards Lifesciences Corp. announced that the companies have reached an agreement to settle all outstanding patent disputes between the companies in all venues around the world. All pending cases or appeals in courts and patent offices between the two companies will be dismissed, and the parties will not litigate patent disputes related to current portfolios of transcatheter aortic valves, certain mitral valve repair devices, and left atrial appendage closure devices. Any injunctions currently in place will be lifted.

The implantation of a MitraClip is guided under live transesophageal echo (TEE). This image shows the operator moving the open clip into position and engaging the mitral valve leaflets. The clip appears as a arrowhead shape in the ultrasound with the leaflets coming off each side. Photo from a MitraClip procedure at the University of Colorado Hospital. Dr. Dominick Wiktor. The TEE is from a Philips Epiq system.
The MitraClip offers a transcatheter repair option and there is growing evidence its use can be expanded to additional patients, including those with heart failure with functional mitral regurgitation.
A live 3-D transesophageal echo (TEE) view using a Philips Epiq system after initial deployment of a Mitraclip. The 3-D images are used to help determine the placement of the clip arms and the how well the valve leaflets are engaged. Photo from a MitraClip procedure at the University of Colorado Hospital.
The implantation of a MitraClip takes a heart team. Three cardiologists are seen here and off frame is an anesthesiologist, echocardiographer and the cath lab support staff. Photo from a MitraClip procedure at the University of Colorado Hospital with doctors Dominick Wiktor and John Carroll.
Live transesophageal echo (TEE) is used to guide MitraClip procedures and color Doppler flow is used to show the exact location of regurgitant jets and to verify if the clip is placed in an optimal position to reduce the jets prior to final deployment. a post deployment color flow Doppler is used to determine is another clip is needed and to document the level of any residual regurgitation. Photo from a MitraClip procedure at the University of Colorado Hospital. Dr. Dominick Wiktor. The TEE is from a Philip

Mitral regurgitation (MR) is one of the most common types of heart valve diseases in the United States, affecting approximately one in 10 adults age 75 and older. About 3 to 4 percent of the population has moderate to severe degenerative MR. It is a progressive disease that, without treatment, leads to a cascade of events that typically progress to heart failure and death.[1]
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