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]
Researchers raised the question whether an economic benefit should be assessed in FDA reviews. A large amount of the bill for atrial fibrillation catheter ablation procedures is the cost of the mapping and ablation catheters.
Chart 1: Medical device trials started by year, USA. Source: clinicaltrials.gov
Table 1: Outcomes in AF device clinical trials identifications generated from clinicaltrials.gov using the following keywords: atrial fibrillation, electrophysiology, ablation therapy, United States.

In an age when everything in medicine is now looked at though a cost vs. benefit analysis and U.S. government healthcare reform efforts focus on cutting costs, the U.S. Food and Drug Administration (FDA) has not introduced economic considerations into its product evaluations. The FDA currently has a formal evaluation process for medical devices looking at safety and efficacy prior to market clearance. But, in light of the economic forces that drive usage of these devices, the question is raised whether economic considerations should also be added as part of the FDA review. 
The startup company Genetesis introduced a new cardiac imaging modalityit calls magnetocardiography. The scanner creates images from the biomagnetic activity of the heart, using the polarization and depolarization of the heart during the cardiac cycle. This was at AHA.18, AHA 2018 - the American Heart Association annual meeting
This was at AHA.18, AHA 2018 - the American Heart Association annual meeting.
Start up company Skylab showed a new ECG ring that the patient wears and interfaces with a smartphone app for automated analysis of the waveforms. The company's studies found it had 96 percent accuracy for detecting atrial fibrillation. This was at AHA.18, AHA 2018 - the American Heart Association annual meeting.
Key news and trends from AHA 2018

Here are a few of the takeaways from the clinical studies presented and new technology shown on the exhibit floor at the 2018 American Heart Association (AHA) annual meeting in November.  

 

Radiological Society of North America (RSNA)

An implanted ICD showing its three venous leads. These multiple CRT leads can cause issues when they need to be replaced and are abandoned with new leads put over them in the SVC, which may require lead extraction.
Cook lead extraction cutting sheaths being guided over an EP device lead.
The Spectranetics Bridge occlusion balloon offers a safety net during lead extractions. It can be inflated to occlude the SVC if there are life threatening tears.
Bruce Wilkoff, M.D., from Cleveland Clinic, is one of the top experts in lead management.
A Cook mechanical cutting system used for lead extraction.

To extract or abandon broken or infected implantable, venous electrophysiology (EP) device leads has been a debate for more than 20 years. Some EPs argue there is a major risk to patients if old pacemaker or implantable cardioverter defibrillator (ICD) leads are extracted. Heavy scar tissue encases the leads after implant, and rough tugging to pull them out may cause the large veins to tear, which can be catastrophic.
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