Carlos G Santos-Gallego, MD on the challenge’s physicians might face selecting which patients should be treated with RDN.

Surgeries & Interventions

Recor Medical’s Paradise Renal Denervation System Lands FDA Approval

The renal denervation race hit a major new milestone this week after Recor Medical’s Paradise system became the first to land FDA approval.

• Renal denervation (RDN) is intended for hypertension that can’t be controlled by conventional therapies, either due to ineffectiveness, side effects, or adherence issues
• RDN lowers blood pressure by denervating the sympathetic nerves surrounding renal arteries, reducing overactivity that can lead to hypertension
• Recor’s ultrasound-based Paradise System has been in development for 14 years, and gained European approval all the way back in 2012

Some might have seen this approval coming after an FDA expert panel endorsed the Paradise System in August, voting 10-to-2 that its benefits outweigh its risks.

• That was a far stronger result than Medtronic’s RDN system, which fell short with a 6-to-7 vote, but is still seen by some as on a path towards FDA approval.

The Paradise System’s FDA approval and panel endorsement were supported by Recor’s pivotal RADIANCE II trial, which found that the RDN system met both primary safety and effectiveness endpoints without any major adverse events.

• In fact, all three of Recor’s sham-controlled RADIANCE RCTs have met their safety and efficacy endpoints, including two off-medication trials that achieved a -4.5 mmHg average BP reduction.

Being first to market comes with obvious advantages, but online and conference chatter suggests that the Paradise System (and RDN in general) will face its share of post-approval challenges:

• Earning physicians’ trust in its impact and durability, and their confidence in identifying patients who are most likely to respond to RDN
• Overcoming physicians’ pharmaceutical-focused approach to hypertension
• Achieving reimbursements and a spot in clinical workflows

The Takeaway

The staggering number of Americans living with uncontrolled hypertension and the clinicians who care for them now have a new tool to help bring their blood pressure under control. That could be huge for these millions of patients, and for Recor Medical, which is now the clear frontrunner in what might prove to be a multi-billion dollar market.

Scaling Your Cardiovascular CT Service With CT-FFR

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The Wire

• Silence Therapeutics’ Promising Phase 1: Silence Therapeutics reported promising phase 1 results for Zerlasiran, an siRNA therapy aimed at lowering Lp(a) levels. During the trial (n=36), patients who received the highest doses (450mg) saw a 99% reduction in Lp(a) levels at 90 days, which stabilized at a 90% reduction by 201 days. Zerlasiran showed a strong safety profile, as well as dose-dependent decreases in LDL-C and ApoB.

• Shockwave’s Add-On Code: Shockwave landed a 2024 add-on CPT code for procedures involving Coronary IVL (code: +92972), adding +2.97 work RVUs and $140 in additional payments for each procedure. The add-on code would represent a 24-30% wRVU increase and a 22-28% payment increase compared to the same procedures without Coronary IVL, and comes shortly after CMS increased inpatient PCI procedure reimbursements by $4k when performed using Coronary IVL.

• CVRx Outpatient Reimbursement Boost: CVRx will also see a reimbursement boost in 2024, after CMS assigned its Barostim procedure a New Technology APC 1580 OPPS code. Outpatient Barostim procedures will now have a $45k average reimbursement, up considerably from its $29k average reimbursement in 2023. Barostim is a neuromodulation heart failure treatment device that works by stimulating baroreceptors, which tell the nervous system how to regulate the heart. 

• Novartis’ HDAC6 Inhibitor Contract: Novartis signed an up-to $1.3B deal with Chong Kun Dang Pharmaceuticals that will give it exclusive global development and commercialization rights for the South Korean biotech’s early-stage HDAC6 inhibitor CKD-510 (except in Korea). CKD-510 has shown efficacy for treating Afib, although many headlines focused on its potential for treating Charcot-Marie-Tooth disease. The deal includes $80M up-front, with other payments based on future milestones.

• Bempedoic Acid Proves Safe: New analysis of the CLEAR Outcomes trial (n=13,970) highlighted the long-term safety of bempedoic acid among high CV risk patients. The results confirm that bempedoic acid’s known risk of gout did not worsen over time, while both groups had similar rates of Afib, tendinopathies, and benign prostatic hyperplasia. Cholelithiasis rates were slightly higher with bempedoic acid (2.2% vs. 1.2%), but ultimately the findings confirm that bempedoic acid’s benefits outweigh its risks. Previous Clear Outcomes analysis highlighted its impact on CV events.

• RDN + Antihypertensives: Is renal denervation (RDN) effective with antihypertensives? This JACC-published randomized controlled trial (n=337) suggests that it is. Researchers gave all patients antihypertensives, along with either Medtronic’s radiofrequency RDN or a sham control procedure, finding that both groups had similar primary outcomes (24hr ambulatory systolic BP at six months). However, the RDN group showed a greater decrease in their BP than the sham procedure group (adjusted treatment difference: -4.9mm Hg).

• Agamon & Mayo Follow-Up: Follow-up care management solutions company Agamon Health entered into a know-how agreement with Mayo Clinic aimed at developing workflows that close follow-up gaps in cardiovascular care. Agamon Health got its start developing solutions that identify incidental radiology findings and ensure clinical follow-ups, and the new Mayo collaboration will focus on ensuring adherence to guideline-recommended cardiology follow-ups – apparently starting with aortic stenosis.

• Trends in CTO PCI: Two studies from the PROGRESS-CTO registry illuminated trends in the performance of antegrade dissection and reentry (ADR) and retrograde techniques for chronic total occlusion PCI. The retrograde approach was performed twice as often as ADR (34.4% vs. 18.6%) with a similar success rate (60.5% and 62%). Meanwhile, the retrograde technique is seeing more use upfront in riskier procedures, and ADR is being used more as a “bailout strategy.”

• Coaching Improves Cardiometabolic Outcomes: Welldoc published real-world study results for 71 type 2 diabetes patients enrolled in a virtual program aimed at improving nutrition and optimizing medications. Participants who engaged with Welldoc’s continuous AI coaching saw their weight fall from an average of 227.8 lbs to 211.8 lbs (average engagement of 256 days). There were also significant improvements in systolic blood pressure and post-meal blood glucose, demonstrating how behavioral coaching can be used to reduce overall cardiovascular risk in a high-risk population at scale.

• Dietary Manganese’s Cardiovascular Potential: Our bodies use the protein complex COPII to pack and send fats via lipoproteins in the bloodstream, and researchers have now discovered that COPII uses the mineral manganese to pack these fats efficiently. They also found that controlling manganese levels might have a significant cardiovascular impact. By simply feeding mice manganese, the team not only treated pathological hyperlipidemia, but actually reversed the buildup of atherosclerotic plaque.

• The Burden of Healthcare Costs: A Commonwealth Fund report gave a grim look at the burden of US healthcare costs, with half of working-age adults struggling to afford care and a third saddled with medical debt. Whether their coverage was through an employer, Medicaid, or Medicare, about 3 in 10 people reported that the cost of care cuts into their food and utility budget. On top of that, almost 40% reported skipping or delaying care in the past year due to the cost, and 57% of this group said their health worsened as a result.

Us2.ai’s Heart Failure Screening Impact

See how Us2.ai’s echo AI solution improved heart failure screening in the NHS, reducing echo waiting times from 12 months to under 6 weeks.

Start Measuring What Matters

Looking to optimize your cardiovascular imaging services, but don’t know what to measure? Check out this Change Healthcare report for insights on how to track and evaluate your cardiovascular imaging performance, assess quality, and enhance operational efficiency. Read the full article now and start measuring what matters!

The Resource Wire

• Atrial fibrillation is often difficult to characterize with an automated algorithm due to the changing waveform morphology, system, or muscle noise. This is especially true given the size constraints of ambulatory devices to detect AFib. See how Monebo’s Kinetic AF ECG Algorithm overcomes these size limitations without sacrificing accuracy.

• HeartFlow’s new RoadMap Analysis solution allows CT readers to accurately, efficiently, and consistently identify stenoses in the coronary arteries. See how RoadMap Analysis’ visual and quantitative insights into the narrowing of all major coronary arteries helps readers evaluate coronary CT angiograms before determining the need for an FFRCT.

• Join Medtronic’s expert faculty for a live, case-based discussion on November 14 at 7:00 p.m. ET. Over the course of 90 minutes, they will discuss durability and TAVR and evidence review designed to expand your TAVR expertise. Register now!

• The emergence of AI CAC detection and new CVD treatments could transform preventative CVD care. Check out this Johns Hopkins editorial in JACC detailing how solutions like Bunkerhill Health’s Incidental CAC algorithm can create opportunities for more effective preventative CVD care, but only if providers seize that opportunity.