Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies.

Transcaval TAVR a safe, effective alternative for patients with severe AS
Researchers examined data from eight different studies, noting that transcaval TAVR appears to be a "viable alternative" when transfemoral access is not an option. The procedure was linked to an overall success rate of 98.5%.
FDA announces new Class I recall of CPET devices due to choking hazard
If left unchecked, the devices could put patients at risk of serious injuries or death as they undergo cardiopulmonary evaluations.
Pfizer recalls 2 drugs, including 1 for hypertension, over safety concerns
The recall was put in place due to a leak risk that could make the therapies less effective and potentially lead to an infection.
AVR for moderate AS: New 10-year data highlight clear benefits of TAVR, surgery
New research out of Cleveland Clinic explored long-term outcomes among patients with moderate aortic stenosis who were treated with TAVR, SAVR or clinical surveillance. TAVR and SAVR were both associated with clear improvements compared to surveillance alone.
Women remain underrepresented in revascularization trials—can cardiology leaders reverse that trend?
“If together we do not just hope for, but demand, adequate representation as a necessary criterion for high-quality studies worthy of adoption into practice, we will have a real shot at achieving true equity in our trials," cardiologists said in a new commentary.

FDA announces new Class I recall of troubled heart devices

The recall includes approximately 2,300 devices distributed to customers prior to July 24, 2017. There have been 44 complaints about this issue so far.

March 17, 2023

Medtronic gains key approval for new mapping and ablation system

Medtronic acquired the technology in a 2022 deal reportedly worth $925 million.

March 16, 2023

venture capital corporate suit business corporatization

Medtronic, Edwards among the healthcare organizations chosen as World’s Most Ethical Companies in 2023

The annual list, now in its 17th year, was designed to celebrate companies that make ethical business practices a high priority.

March 16, 2023

a patient talks with her doctor, both are women of color

Cardiologists warn Biden administration that new policies could put PAD patients at risk

SCAI and the Association of Black Cardiologists have joined forces to share a simple message: PAD patients would be negatively impacted by new CMS proposals.

March 8, 2023

The Millipede 088 Access Catheter. Image courtesy of Perfuze. FDA clearance.

Regulatory Roundup: FDA clears 2 new solutions, declines to approve omecamtiv mecarbil for HFrEF

Read our monthly recap of FDA-related news items from the world of cardiovascular medicine.

March 1, 2023

Abbott and the U.S. Food and Drug Administration (FDA) are warning healthcare providers about the potential risk of early structural valve deterioration (SVD) with Abbott’s line of Trifecta bioprosthetic heart valves. This includes the original Trifecta valve and the Trifecta GT, which are both designed to treat disease, damaged or malfunctioning aortic heart valves.

FDA warns that early deterioration is possible with Abbott’s Trifecta heart valves

Early SVD has been reported in these devices, particularly three to four years after implantation. According to the FDA, this has resulted in surgical replacement procedures and transcatheter valve-in-valve interventions. In some cases, the patient died.

February 27, 2023

The Medtronic Harmony transcatheter pulmonary valve on display at ACC 2022. The U.S. Food and Drug Administration (FDA) has announced that Medtronic is recalling the delivery catheter from its Harmony transcatheter pulmonary valve (TPV) system due to a risk of the piece breaking during use.

Medtronic relaunches Harmony TPV system after 2022 recall

The device, which gained FDA approval in 2021, was part of a voluntary recall in 2022 due to stability concerns. Medtronic worked with the FDA to address the issue, and the Harmony TPV is once again available throughout the United States.

February 23, 2023

Interventional cardiologists performing PCI

New ACC/AHA/SCAI guidance highlights training requirements for interventional cardiologists

The document, which was designed to help guide both interventional cardiology trainees and program directors, was also endorsed by several other industry societies.

February 22, 2023

Around the web

Health Imaging

New imaging protocols proposed to curb rise of cardiovascular infections

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

Radiology Business

What does radiology have to do with climate change?

Kate Hanneman, MD, explains why many vendors and hospitals want to lower radiology's impact on the environment. "Taking steps to reduce the carbon footprint in healthcare isn’t just an opportunity," she said. "It’s also a responsibility."

Policy & Regulations

Transcaval TAVR a safe, effective alternative for patients with severe AS

FDA announces new Class I recall of CPET devices due to choking hazard

Pfizer recalls 2 drugs, including 1 for hypertension, over safety concerns

AVR for moderate AS: New 10-year data highlight clear benefits of TAVR, surgery

Women remain underrepresented in revascularization trials—can cardiology leaders reverse that trend?

Around the web