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Key Takeaways from HRX Live 2026: Medtronic, Orchestra and KOLs Discuss AVIM Therapy & Expanding the Role of Cardiac Pacing to the Treatment of Hypertensive Heart Disease

Orchestra BioMed Investor Relations Blog | October 2026

 

Cardiac pacing has long focused on treating slow or irregular heart rhythms. At HRX Live 2026, clinicians and industry leaders explored how our investigational AVIM Therapy could expand that role by addressing hypertension, the most common comorbidity in pacemaker patients.

In a roundtable moderated by Vivek Reddy, MD, of Mount Sinai, panelists Robert C. Kowal, MD, PhD, of Medtronic; Andrea Russo, MD, of Cooper University Hospital; Charles Love, MD, of Johns Hopkins Hospital; and David Hochman, Chairman, CEO and Founder of Orchestra BioMed, examined the evidence behind that approach and where it could lead.

Hochman and Dr. Kowal also joined Heart Rhythm TV for a separate interview exploring the collaboration behind AVIM Therapy and the BACKBEAT Global Pivotal Trial.

 

1. The Orchestra BioMed–Medtronic partnership is working to expand what a pacemaker can do.

For Dr. Kowal, the partnership reflects a shared vision for pacing beyond bradycardia: Orchestra BioMed’s investigational approach to hypertension aligned with Medtronic’s interest in expanding what a pacemaker could accomplish.

Orchestra BioMed leads therapy development and clinical execution, while Medtronic provides established pacing technology and global commercialization infrastructure. As Dr. Kowal explained, “what everyone was bringing to the table was perfect.” These complementary roles let each partner focus on its strengths as they advance the clinical program and prepare for potential commercialization, subject to positive data and regulatory approval.

 

 

2. A 10-mmHg reduction in blood pressure can meaningfully improve cardiovascular outcomes.

Hypertension is the most common comorbidity in pacemaker patients and it drives or further complicates most of the cardiovascular events (e.g. heart attack, stroke) and conditions (e.g. coronary disease, heart failure) that cardiologists treat or work to prevent. Dr. Russo emphasized that even a 10-mmHg reduction in blood pressure can meaningfully improve cardiovascular outcomes, including reducing heart failure events and mortality.

Blood pressure control becomes difficult to achieve and sustain when patients face medication side effects or challenges with adherence. For people who already need a pacemaker, the possibility of delivering blood pressure therapy through that device offers a practical reason to study AVIM Therapy alongside existing antihypertensive treatment.

 

 

3. Treating hypertension offers an opportunity to intervene earlier in the progression of cardiovascular disease.

Beyond improving outcomes for patients, the importance of blood pressure control extends to the progression of disease itself. Hochman described hypertension as “the trunk of the tree” of cardiovascular disease, with stroke, heart attack and the progression of heart failure and kidney disease all branching from it.

Hochman tied that view to early observations of reduced cardiac workload, improved diastolic function and smaller left ventricular size. These findings have helped shape AVIM Therapy’s focus on hypertensive heart disease and the potential longer-term opportunity to intervene before hypertension’s downstream consequences take hold.

 

 

4. AVIM Therapy pilot studies have shown immediate and sustained blood pressure reductions.

The evidence generated in the pilot studies has given investigators a foundation that helped drive completion of patient enrollment in the BACKBEAT Global Pivotal Trial. Across the prior AVIM Therapy clinical development program, including the randomized, double-blind MODERATO II study, the panel highlighted data demonstrating immediate blood pressure responses when therapy was activated and sustained reductions captured through ambulatory monitoring during follow-up.

Dr. Reddy referred to the ambulatory blood pressure reductions as “extraordinary,” while Dr. Russo stressed their durability, noting encouraging changes in cardiac volumes. The BACKBEAT Global Pivotal Trial is evaluating the therapy at a larger scale in pacemaker-indicated patients with uncontrolled hypertension. Its randomized, double-blind design is intended to assess safety and efficacy at 3-month primary endpoint as well as longer-term 12-month secondary endpoints.

 

 

5. Early findings on cardiac function suggest AVIM Therapy may have future applications in HFpEF.

Those cardiac observations also raised the possibility of future applications in patients with heart failure with preserved ejection fraction, or HFpEF. Dr. Russo discussed the challenges in treating diastolic heart failure and the potential relevance of a therapy that could influence cardiac remodeling as well as blood pressure.

Dr. Reddy had similar interest and optimism for AVIM Therapy’s potential impact in the space, reflecting on the many innovative HFpEF strategies that have struggled in clinical development. These early findings identify a direction for future research into the potential benefits of AVIM Therapy in HFpEF patients.

 

 

6. AVIM Therapy could one day become as central to electrophysiology practice as catheter ablation.

The conversation closed with a look at the evolving landscape of electrophysiology practice. Dr. Reddy compared AVIM Therapy’s potential reach to that of catheter ablation today, suggesting it “may actually occupy most of our time, even more than what we do today with catheter ablation.”

That vision extends beyond the patients being studied in the BACKBEAT Global Pivotal Trial. The panel considered future development with leadless pacing and the prospect of eventually treating people with uncontrolled hypertension who do not have a conventional pacemaker indication.

 

 

Watch the full HRX Live 2026 roundtable for the complete discussion of AVIM Therapy, the clinical program and the Orchestra BioMed–Medtronic strategic collaboration.

 

Watch David Hochman and Rob Kowal discuss the collaboration behind AVIM Therapy

In a separate conversation recorded at HRX Live 2026, CEO David Hochman and Medtronic’s Dr. Robert Kowal joined Heart Rhythm TV host Oliver Monfredi to discuss how their collaboration brings together therapy innovation and established pacing technology. The interview explores how AVIM Therapy works, the design of the BACKBEAT Global Pivotal Trial, and the potential path toward commercialization.

Watch the full Heart Rhythm TV interview

Recorded in September 2026.

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