FDA lifts injunction on Philips defibrillators
Last April the FDA gave Philips the green light for its Emergency Care and Resuscitation business to resume development and distribution of defibrillators in the U.S., following a two-and-a-half-year injunction.

The injunction was issued through a consent decree in November 2017 after the FDA accused the company of violating current good manufacturing requirements mandated by the Federal Food, Drug and Cosmetic Act (FD&C Act) and of being noncompliant with quality system regulations in its manufacturing of AEDs and Q-CPR Meters.

"The injunction lift is an important milestone for Philips, as we have enhanced the regulatory compliance processes in our ECR business and throughout the company," said Frans van Houten, CEO of Royal Philips, in a statement. "Providing our customers with safe and reliable products and solutions remains our highest priority, and I am proud that our AEDs save lives daily, with their very high reliability record."

The injunction required the Dutch healthcare giant to stop manufacturing defibrillators at two U.S. facilities until the FDA could inspect and certify that the sites complied with Quality System Regulations.

Philips subsequently restructured its quality control function and appointed new leadership, retrained personnel and introduced culture change initiatives to become compliant with the necessary regulations.

Robotic PCI exposes patients to 20% less radiation, says new study
Applying robotic percutaneous coronary intervention exposes patients to 20% less exposure compared to manual PCI, according to a study in May by Corindus, a Siemens Healthineers company. The investigators found that using a robotic PCI solution like Corindus’ CorPath GRX System cuts the amount of exposure for patients without increasing fluoroscopy time or contrast utilization.

“CorPath GRX is designed to remove the physician from the radiation field during the procedure,” Corindus CEO Mark Toland told HCB News. “They control the robot while watching a high-definition monitor from behind a protective shield or inside a control room adjacent to the lab. This reduces physician radiation exposure by over 95%.”

Fluoroscopy systems expose interventional cardiology patients to more radiation than any other medical specialty, putting them at increased risk for cancer, cataracts, and other radiation-related illnesses. The authors note that raising the table, and hence, the patient, away from the radiation source is associated with minimized dose exposure. Robotics can perform this maneuver without limiting the operator’s ability to work, as the devices are being held and driven inside the robot.

In addition to reducing radiation exposure, the positioning of CorPath GRX provides the operating physician with greater visualization of the case than they would have if using manual PCI, due to closer proximity to the angiographic images.

AI software for cardiac echo could help in COVID-19 fight
A U.K. company with software that uses AI to predict the likelihood of a patient developing coronary artery disease entered into a clinical research agreement with Mayo Clinic in late May to further develop the product.

The partnership will also explore using AI analysis of echocardiograms to potentially help triage COVID-19 patients, as heart disease is associated with worse outcomes.

Ultromics, which spun out of research at Oxford University, markets the EchoGo Core and EchoGo Pro, which applies AI to echocardiograms to better diagnose heart disease.

The EchoGo Core product, which is FDA cleared, provides automated scores for ejection fraction and Global Longitudinal Strain. Without the device, the scores are only 76% accurate and highly variable based on which clinician performs the calculations, said Ross Upton, Ultromics’ chief executive officer.

The company’s EchoGo Pro product, which is CE marked but has not yet been submitted for FDA clearance, predicts whether a patient is at risk of a heart attack and requires intervention.

The partnership will allow Ultromics to use Mayo Clinic’s extensive cardiac data sets to help develop the company’s image analysis product suite. Mayo Clinic will use EchoGo Core to analyze echocardiograms of COVID-19 patients, to better understand how the virus affects the cardiovascular system.

Ziehm Imaging acquires French-based imaging software developer Therenva
With the acquisition of Therenva in late July, Ziehm Imaging is aiming to leverage its distribution network of mobile C-arms to market the French-based software developer's imaging software portfolio globally.

Building on a two-year market cooperation in Europe, the combined companies will focus on the cardiovascular image fusion and 3D navigation solutions. Further down the line, the combined companies are poised to develop new solutions for pre- and intraoperative image-based decision support in cardiovascular, and potentially other clinical areas.

“We are really excited to extend our partnership and work even closer together with the committed team at Therenva,” Klaus Hörndler, CEO at Ziehm Imaging, said in a statement. “The Therenva portfolio is the perfect addition to our leading C-arm portfolio, and we look very much forward to further driving the OR integration in the future together.”

Therenva has designed advanced and user-friendly imaging software tool sets for cardiovascular procedures since 2007. According to a statement, the company's EndoNaut endovascular navigation solution is ideal for connection with the Ziehm Vision RFD Hybrid Edition mobile C-arm.

Philips to acquire Intact Vascular with upfront cash offer of $275 million
In August, Philips announced it was set to acquire Intact Vascular for an upfront cash consideration of $275 million (€234 million) — a move that expands its image-guided therapy portfolio.

A U.S. developer of medical devices for minimally-invasive peripheral vascular procedures, Intact Vascular will integrate its specialized implantable device, Tack Endovascular System, for treating Peripheral Artery Disease (PAD) with Philips’ interventional imaging platform and diagnostic and therapeutic devices.

"Through the integration of our interventional imaging systems and diagnostic and therapeutic devices, we will be able to provide clinicians with a complete procedural solution to optimize the treatment of patients with this disease,” said Chris Landon, senior vice president and general manager of image-guided therapy devices at Philips.

PAD affects more than 200 million people worldwide, with plaque building up in the arteries and reducing blood flow to the limbs, most commonly the legs. This can lead to recurrent fatigue, leg pain, foot or leg wounds, and critical limb ischemia (CLI).

The Tack Endovascular System enables patients to receive standard and drug-coated balloon PAD treatment results. The minimal-metal, dissection repair device precisely treats peripheral artery dissections following balloon angioplasty in above-the-knee and below-the-knee therapeutic interventions. The implant leaves less metal behind compared to stents, preserves future treatment options and preserves limbs. It also repairs dissections and optimizes post-angioplasty outcomes in the challenging CLI patient population.

Stroke admissions drop by nearly a third in early pandemic months
Hospitals saw almost a third as many cases of stroke and mini-stroke (TIA) patients in March and April of 2020 as they did during the same time last year.

That’s what a team of U.S. researchers found in September after reviewing patterns of stroke and mini-stroke admissions, as well as ED stroke alerts, from 2020 and 2019. Many patients are believed to have avoided going to the hospital for care out of fear of COVID-19. This can put them at risk for some neurological deficit associated with that, as well as post-stroke complications, including fatigue, depression, anxiety, and cognitive impairment.

“I think one of the bigger concerns is that with strokes and mini-stroke, the highest risk of recurrence is in the first couple of weeks or months after that initial event,” Dr. Malveeka Sharma, vascular neurologist at the University of Washington, told HCB News. “Our goal in treating someone during that first event is to get them rehabilitated but then also do our best to prevent another event from happening.”

Declines coincided with U.S. stay-at-homes recommendations in late March, with the greatest fall in stroke and TIA admissions occurring between March 23 and April 19, 2020. During this period, there were 281 admissions, compared to 410 in the same period in 2019, a 31% drop.

Henry Ford Allegiance Health opens advanced hybrid operating room
Henry Ford Allegiance Health opened an advanced hybrid operating room in October combining imaging equipment found in a cardiac catheterization lab and specialized features native to an operating room designated for open-heart surgery.

The combination of these resources is expected to create an environment that offers real-time guidance during procedures and enables clinicians to switch from a minimally invasive cardiac operation to open-heart surgery without having to transport the patient to another room.

“The hybrid operating room includes low-dose X-ray imaging, CT abilities, advanced ultrasound modalities, Fractional Flow Reserve, and multidisciplinary interfaces to allow for the seamless integration of future technology,” Susan Wilkinson, a communications specialist for Henry Ford Allegiance Health, told HCB News. “The advanced technology will provide higher quality and safety by bringing all aspects and back-up scenarios of a patient’s care into one place for greater efficiency and expediency.”

Patients needing a conversion from a minimally invasive cardiac procedure to open-heart surgery had to be transported in the past to an operating room. The elimination of transport can be lifesaving according to the hospital.

To prepare for development of the room, Henry Ford Allegiance Health interventional cardiologists studied with experts from Henry Ford’s Center for Structural Heart Disease for nearly two years.

Kentucky hospital first in US to implant Bluetooth-enabled cardiac device in patient
In October, St. Elizabeth Edgewood became the first U.S. hospital to implant a Bluetooth-enabled biventricular cardiac defibrillator, the Abbott Gallant, within a patient.

"This next-generation device communicates wirelessly to the patient's physician and also lets patients access information about the device using an app on a smartphone," said Dr. Mohamad Sinno, a cardiac electrophysiologist with the St. Elizabeth Heart and Vascular Institute, in a statement.

Research shows that better patient engagement and compliance with monitoring reduces hospitalizations, ensures better clinical outcomes and improves survival. The smartphone connectivity is expected to achieve these objectives by improving patient remote monitoring rates and patient engagement in remote monitoring.

The solution pairs with Abbott’s myMerlinPulse, an iOS- and Android-compatible mobile smartphone app that streamlines communication between doctors and patients. With the app, patients can access their data, device performance and transmission history. Physicians can use the app to monitor patients remotely and identify asymptomatic episodes and patient-triggered transmissions. This enables early intervention and reduces clinical burden.

It also is MR compatible and offers more flexibility than traditional bedside monitors, and enables easy transmission of data mutually. Access to device status such as battery longevity is done in a cybersecure mode with enabled two-way authentication.

New evidence that MR scanning possible with non-MR-compatible cardiac implants
Patients with non-MR-compatible devices for cardiac trouble can safely undergo MR exams, according to a group of researchers who published findings in late October.

While prior research has demonstrated the safety of performing MR procedures on patients with non-MR-conditional devices, not all groups have been accounted for. This includes pacemaker-dependent ICD patients, those with abandoned or fractured leads, patients whose hearts won’t function if their defibrillator is removed or stops working, and those undergoing chest and cardiac MR exams.

"The findings of this study should decrease the level of concern regarding performing MRs in patients with implanted cardiac devices," study lead author Dr. Sanjaya Gupta, of Saint Luke’s Mid America Heart Institute in Kansas City, Missouri, told HCB News. "Essentially, this study shows that virtually all patients with an implanted cardiac electronic device can undergo MR scans safely, regardless if their device is labeled as MR-conditional by the FDA. As we collectively gain more experience with protocols like the one featured in our study, more and more hospitals will offer MR scans to their patients with non-MR-conditional devices."

While all implants today are MR compatible, millions of people worldwide, including young people, have older devices that are not considered compatible.

The findings were published in Radiology: Cardiothoracic Imaging.

Fujifilm makes entry into surgical and fluoroscopy markets
FUJIFILM Medical Systems U.S.A. entered the surgical and fluoroscopy markets in November with the release of its Persona C Surgical C-Arm and Persona RF Premium System.

"As a longtime leader in diagnostic imaging, entering the radiographic fluoroscopy market with the innovative Persona C Surgical C-Arm and Persona RF PREMIUM System is a natural extension to our company and for our customers,” said Hidetoshi Izawa, vice president of modality solutions and clinical affairs at FUJIFILM Medical Systems U.S.A. Inc., in a statement.

The Persona C Surgical C-Arm allows for fast, precise positioning and advanced image quality for different diagnostic imaging and minimally invasive surgical procedures. The mobile C-arm system offers 21x21 cm or 30x30 cm amorphous silicon flat panel detection options for ultra-low-dose fluoroscopy and vascular imaging. It also has a removable grid with 81 cm of free space, and dedicated radiography mode for high-quality still imaging.

The Persona RF Premium System images skeletal, digestive, urinary, respiratory and reproductive systems in real time, as well as specific organs such as the heart, lungs and kidneys. It has a 17x17 DR detector and can be configured with an optional overhead tube crane and upright radiography Bucky.

Both solutions were shown at the 2020 virtual RSNA meeting.

Over 80% drop in SPECT-MPI had no impact on rate of abnormal findings
The University of Alabama Medical Center performed over 80% less SPECT myocardial perfusion imaging at the peak of the pandemic.

A retrospective study, however, performed by researchers at the University of Alabama at Birmingham found that the decrease did not create any shift in the rate of abnormal SPECT-MPI findings.

"We hypothesized that due to the highly restricted availability of testing, only high-yield patients will undergo SPECT-MPI, while those expected to be normal would be delayed," the authors wrote in January. "However, we did not find any statistically or clinically significant increase in the rate of abnormal SPECT-MPI or that of myocardial ischemia during this period."

Exams like SPECT-MPI were postponed in accordance with guidelines issued by both the American Society of Nuclear Cardiology and the Society of Nuclear Medicine and Molecular Imaging during the pandemic, leading to significant restrictions.

Comparing the results of 210 patients who underwent SPECT-MPI in March and April 2020 to those of 1,106 who underwent the exam around the same time in 2019, the researchers found SPECT-MPI volumes at the hospital fell from 553 per month to 105, a decrease of 81%. The proportion of abnormal results, however, only dipped from 31% at the baseline to 27% at the peak.

Deep learning system could save time in scoring coronary calcium
Quantifying and scoring coronary calcium may soon be simplified with a deep learning system developed by researchers at Brigham and Women’s Hospital and Massachusetts General Hospital.

While detectable on CT scans, coronary calcium requires radiological expertise, time and specialized equipment to calculate the amount of plaque present. Clinicians often must look at the CT slice by slice for 'bright specks' of calcium in the coronary arteries and circle each one. All the specks are then added up by the software they work with to calculate the coronary artery calcium score.

The automated calcium scores correlated closely with manual, human-made calcium scores and independently predicted who would have a major adverse cardiovascular event. In addition, the inclusion of three National Heart, Lung, and Blood Institute-funded trials in its training further supports the generalizability of these findings to clinical settings, according to the authors.

"The most important next step is the prospective implementation and evaluation of the system in opportunistic and organized screening settings to identify unknown high risk individuals for cardiovascular disease (CVD), and include these individuals into CVD prevention programs. This can lead to an increase of population health," said Dr. Hugo Aerts, director of the Artificial Intelligence in Medicine (AIM) Program at Brigham and Women’s Hospital & Associate Professor at Harvard Medical School.

Apple iPhone 12 magnet may pose risk to cardiac implants
The Apple iPhone 12 series includes a new feature that can accidentally deactivate or interfere with the functioning of cardiac implants.

Researchers at Henry Ford Heart and Vascular Institute discovered a strong magnet in the phone can turn off a defibrillator or deliver electrical pulses to a pacemaker that cause the heart to beat out of sync when the phone is placed near a patient’s chest. This can result in a potentially lethal condition called ventricular fibrillation, a condition in which ventricles of the heart quiver instead of pumping normally due to disorganized electrical activity.

“Obviously, we can’t perform surgery every time we need to control one of these devices, which is why they are engineered to allow us to use strong magnets over the chest to control their function,” said cardiologist and lead investigator Dr. Gurjit Singh in a statement. “So, we began to wonder if the magnet in the iPhone 12 would affect the safe operation of these devices.”

The researchers immediately drafted a manuscript of their findings that caught the attention of the FDA and the Association for the Advancement of Medical Instrumentation (AAMI) upon being published. It also was seen by Apple, which published a warning on its website in late January.