Vinay Badwhar, MD on the future need for TAVR explants in younger patients.

The best way to avoid complications post cardiac surgery might be to prepare patients before the procedure. Check out this Cardiac Wire guest post from Renibus Therapeutics about its investigational agent, RBT-1, that helps reduce oxidative stress and inflammation in patients before they’ve even reached the operating room.

Cardiology Pharmaceuticals

FDA Approves a New BP Triple Polypill

Bringing a more effective BP therapy to the U.S. market, the FDA approved George Medicines’ triple therapy polypill called Widaplik for patients with hypertension, making it the first of its kind to go to market in the U.S.

• The AHA estimates that more than 122M adults have high blood pressure in the U.S., and nearly 40% aren’t aware of it.
• George’s Widaplik contains the ARB telmisartan, calcium-channel blocker amlodipine, and diuretic indapamide, combining the three for effective BP management.
• This makes Widaplik the first triple combination medication approved by the FDA as an initial treatment for patients who need multiple medications to lower BP. 

Widaplik’s approval stems from two studies, including one comparing the polypill against placebo as an initial treatment in patients with hypertension and another comparing the polypill against combinations of two-out-of-three drugs that make up Widaplik.

• In both studies, the polypill resulted in significant and clinically meaningful improvements in blood pressure.
• Those benefits stem both from the three pronged approach to lowering BP, and the reduced medication fatigue and better adherence thanks to only having to take one pill.
• While generally safe across testing, Widaplik’s product label includes an FDA warning for pregnant patients, as the ARB, telmisartan, may cause birth defects.

Further encouraging the BP shift to polypills, a 2023 meta-analysis also found that polypills with three or four combined antihypertensives were significantly better at lowering BP than monotherapy, usual care, or placebo.

• While current guidelines recommend starting with one or two antihypertensives, this requires patients to make frequent visits over several months to get the dose right.
• George’s fixed-dose combination pills containing low doses of three BP-lowering medications now help simplify this process and improve adherence.

The Takeaway

The research over the last couple years has strongly supported the polypill approach when it comes to BP, and the FDA’s approval of George’s Widaplik is an acknowledgement of that. While hypertension remains prevalent in the U.S., Widaplik could become part of the push towards simplifying the condition’s treatment and management.

Heartflow Roadmap Analysis For Efficient Care

As Coronary CT scan volumes increase, your entire reading team needs to deliver efficient and consistent reads. Good thing Heartflow’s Roadmap Analysis can help you maintain accuracy and increase CCTA read speeds by up to 25%, with even level 3 readers seeing real efficiency benefits.

The Path To Modern Enterprise Imaging is in the Cloud

Healthcare needs are changing rapidly, and some imaging systems cannot adapt to an evolving technology landscape. Explore the factors forcing imaging and IT teams to look to the cloud, and what might be holding them back in this Optum infographic.

Explore the latest clinical evidence: SMART Trial 2-year results are in!

Evolut™ TAVR maintains superior valve performance through two years in small annulus patients. Dive
into the key findings from the latest SMART Trial results. View now!

The Wire

• Renibus’ Approach to Surgical Preconditioning: Renibus Therapeutics’ RBT-1 is an investigational agent that activates antioxidant and anti-inflammatory pathways to help prevent post-operative complications like new-onset AFib and AKI. In this exclusive Cardiac Wire profile, Renibus details the outcomes of its Phase 2 RCT and the design of its ongoing PROTECT Phase 3 RCT as it prepares for a regulatory decision following its Fast Track and Breakthrough designations from the FDA.

• First Robotic TAVR Explant: The WVU Heart and Vascular Institute made history by performing the world’s first robotic explant and replacement of a transcatheter aortic valve. This breakthrough started when a 67-year-old female patient presented with a failing TAVR valve and a leaky mitral valve. The team opted for a new robotic method due to the patient’s arthritis and scoliosis. While the technology had never been used in this way before, the operation (TAVR explant and the replacement of both heart valves) was a success. 

• PH and Occult HFpEF: Pulmonary hypertension comes with several challenges and new research suggests occult HFpEF could be part of exercise limiting symptoms for many PH patients. As part of a JHLT study, researchers examined 619 patients with normal resting pulmonary arterial wedge pressure (PAWP) using exercise testing and found that 13% had occult HFpEF. Those same patients also showed significantly higher PAWP passive leg raise which researchers also used to detect occult HFpEF (AUC: 0.75-0.79 depending on age).

• DASHI Predicts MI Risk: Researchers may have developed a new model for predicting the risk of MI and stroke for patients with acute respiratory infections. Pooling data from 3.8M patients with acute respiratory infections, researchers created the “DASHI” score (diabetes, age, current smoking, heart failure, and infection type) and found that the score showed good discrimination (AUC 0.85) and calibration when it came to predicting a patient’s stroke or MI risk.

• RNA Drug for Ischemic HD: Shanghai CirCode Biomed’s HM2002 ischemic heart disease drug received Investigational New Drug clearance from the FDA. HM2002 is an RNA drug that works by making heart muscle cells continuously express vascular endothelial growth factor to promote angiogenesis, improve myocardial perfusion, and facilitate cardiac function recovery. A single dose of HM2002 can reportedly express VEGF protein for a “perfect time window” in vivo – one that is long enough for efficient angiogenesis, but short enough to avoid safety concerns.

• Regeneron Improves Semaglutide: Tackling a major GLP-1 issue, Regeneron Pharmaceuticals announced interim results from its Phase 2 COURAGE trial that combined semaglutide with its anti-myostatin antibody trevogrumab. The trial demonstrated that 35% of semaglutide-induced weight loss was from lean mass loss (muscle), and further found that combining semaglutide with trevogrumab helped preserve lean body mass (50.8%-51.3% preservation). The results were even better in patients who took Regeneron’s activin A blocking antibody, garetosmab, alongside semaglutide and trevogrumab (80.9% preservation).

• Duvyzat Comes to DMD: The European Commission granted conditional marketing authorisation for Italfarmaco’s Duvyzat (givinostat) for treating Duchenne muscular dystrophy (which can cause cardiomyopathy). Duvyzat is a novel histone deacetylase (HDAC) inhibitor that regulates excessive HDAC activity in DMD muscles which helps restore gene expression for muscle maintenance and repair. The approval is based on the positive results of the EPIDYS Phase 3 RCT, which demonstrated a statistically significant and meaningful difference in DMD patients’ stair climbing ability.

• Treating Combined AS & ATTR: More studies are exploring how the combination of AS and ATTR-CA leads to structural HF, and a new EHJ study suggests ATTR-specific meds (tafamidis) could help improve outcomes after aortic valve replacement. Among 226 patients with AS and ATTR-CA, those who received tafamidis following valve replacement faced a lower all-cause and CV mortality rate (HRs: 0.40, 0.47) compared to the control group. However, tafamidis did not impact the rate of structural HF and it’s worth noting this wasn’t an RCT.

• P2Y12s vs. Aspirin Post-PCI: Long term P2Y12 inhibitor monotherapy with ticagrelor or clopidogrel could be better than aspirin in PCI patients after stopping DAPT. Researchers assigned 16k patients to receive either a P2Y12 inhibitor or aspirin after their PCI/DAPT discontinuation and found that P2Y12 inhibitor monotherapy was associated with a 23% lower MACCE risk compared to those on aspirin after a 5.5 year follow-up. These improvements stem from lower MI and stroke risks, but P2Y12 inhibitors didn’t impact major bleeding risk.

• The First Polymer MV: Utah-based Foldax announced that its polymer Tria mitral valve received commercial use approval in India, making it the first polymer heart valve to secure regulatory approval anywhere in the world. The Tria surgical mitral valve is built using LifePolymer, which doesn’t include animal tissue and its leaflets and frame are robotically generated to match each patient’s native mitral valve. The new polymer is designed to reduce the long-term risk of valve calcification and could potentially allow patients to avoid long-term anticoagulant use.

• Atraverse Attracts New Capital: Atraverse Medical closed a $29.4M follow-on financing round (over $40M raised to date) to accelerate the commercialization of its HOTWIRE radiofrequency guidewire for left-heart access. The fresh funds will be used to scale Atraverse’s manufacturing, team, and product development. The company’s current commercialization strategy focuses on HOTWIRE’s universal sheath compatibility and a zero-exchange workflow that are designed to simplify left-heart access for catheter-based therapies.

Identify and Treat Cardiovascular Disease

Complex care pathways make getting patients to the next step a challenge. See how Tempus Next, an AI enabled care pathway platform, helps providers identify and reduce under treatment in cardiovascular disease by adding an intelligent layer onto their routinely generated EHR data.

Explore Vitrea Advanced Visualization

Discover Canon Medical Healthcare IT’s suite of advanced imaging workflows designed to increase efficiency in cardiovascular imaging, and facilitate the assessment, diagnosis, and treatment of cardiovascular diseases. These cutting-edge tools support the delivery of faster, more accurate care while integrating seamlessly into clinical workflow

The Monebo Difference in Comprehensive Cardiac Mapping

Monitoring the heart 24/7 means being in tune with the body’s natural cycles. Read about how Monebo’s approach to cardiac monitoring provides visual representations of a patient’s heart rate, cardiac muscle relaxation, and electrical excitation throughout the day.

The Resource Wire

• Patient Attitudes Towards Us2.ai’s AI-Echo: The medical imaging field is rapidly accepting AI, but how are patients feeling about the shift? Get the scoop on patients’ positive opinions toward Us2.ai’s software that supports task shifting from conventional echo to AI-echo.

• Left Ventricular Devices Have Received Level 1A Recommendation: Patients on long-term inotrope support have a median survival of under a year.

• How Vista AI Helps Solve the Technologist Shortage: Fewer than 2% of MRI scanners are routinely used for cardiac imaging—mainly due to a shortage of trained technologists amid rising demand. Vista AI addresses this challenge by automating CMR scanning, empowering technologists of all experience levels to deliver high-quality cardiac exams consistently and efficiently.

• Addressing Coronary Artery Disease: Learn how the AGENT™ Drug-Coated Balloon provides a new treatment option for in-stent restenosis in the U.S. Rx Only. (Sponsored by Boston Scientific)

• Automated and Intelligent EP Reporting: EP ablation procedures are difficult, but your EP reporting process shouldn’t be. See how GE HealthCare’s Centricity EP Structured Reporting allows for quick, accurate, and complete reporting in as few steps as possible.

• The Benefits of Outsourced Post-Processing: Using an outsourced cardiac image post-processing solution doesn’t have to mean sacrificing control of the results. Discover how PIA’s customizable post-processing workflow can help you get the most out of your images.

• Revolutionize Your Cardiac CT Workflow — See It LIVE at SCCT 2025! Be among the first to experience next-gen CV imaging at Booth #315 during SCCT 2025. Sign up now to find out how Circle CVI’s software enables lightning-fast LAAC, TAVR, and TMVR workflows while providing more accurate heart function insights, and clinician-controlled plaque quantification.

• Your Cardiology Data is Valuable. Put it To Work. See how one major Midwest health system’s decision to implement Merge Cardio transformed physician and staff workflows, improved data entry speed and accuracy, and increased cost savings.

• A Better Way to Coordinate Post-Stroke Care: Think your EHR messaging system might be holding back your post-stroke care? See how UC San Diego Medical Center streamlined its neuro and EP teams’ post-stroke workflow with Viz Connect, and the impact it had on cardiac monitor placements in inpatient and outpatient settings.

The Industry Wire

1. States file lawsuits to block sale of 23andMe DNA data. 
2. Trump health officials outline new FDA priorities.
3. RFK, Jr. fires COVID-19 vaccine advisory panel. 
4. NIH workers protest research funding cuts. 
5. New Oregon law limits corporate healthcare ownership.
6. Do GLP-1 drugs cause “Ozempic teeth?”
7. J&J unit hit with $442M antitrust ruling over catheters.
8. UnitedHealth scrutiny ramps up after whistleblower report.
9. How AI agents will revolutionize healthcare. 
10. BlueShield of California ties up with Zocdoc for scheduling.