Hypertension affects over 1 billion people worldwide.
According to the World Health Organization (WHO), high blood pressure is a major risk factor for coronary heart disease and ischemic as well as hemorrhagic stroke.
- In some age groups, the risk of cardiovascular disease doubles for each increment of 20/10 mmHg of blood pressure, starting as low as 115/75 mmHg.
- In addition to coronary heart diseases and stroke, complications of raised blood pressure include heart failure, peripheral vascular disease, renal impairment, retinal hemorrhage and visual impairment.
- Treating systolic blood pressure and diastolic blood pressure until they are less than 140/90 mmHg is associated with a reduction in cardiovascular complications.
Despite advances in pharmacological therapy and access to advanced healthcare, over 50% of patients with hypertension suffer from uncontrolled high blood pressure, suggesting that there is a significant underserved market at increased risk for heart disease and stroke.
A New Area Of Research
For patients unable to effectively control their blood pressure with lifestyle changes and medication therapy, a new class of interventional catheters are under development for the treatment of hypertension.
Transcatheter Perivascular Denervation
Increased sympathetic nerve activity plays a key role in the pathophysiology of hypertension, affecting blood pressure (BP) modulation through efferent and afferent pathways. The potential to reduce BP by interrupting sympathetic nerve activity was first described in the 1930s through 1950s in published articles explaining surgical sympathectomy.
Recently catheter-based renal denervation (RDN) has emerged as a promising minimally invasive approach to the treatment of hypertension.
Ablative Solutions is on the forefront of this new field of research called renal denervation. The Peregrine System Infusion Catheter developed by Ablative Solutions offers the potential to provide enhanced delivery of renal denervation therapy for the treatment of hypertension. This novel approach being developed by Ablative Solutions is called Transcatheter Perivascular Denervation.
Using a catheter-based percutaneous approach, the Peregrine System Infusion Catheter enables the physician to infuse a neurolytic agent directly into the perivascular space where the sympathetic nerves are located.
The Peregrine catheter features three microneedles for the infusion of solutions. Utilizing a technique very similar to routine coronary or peripheral catheterization, the catheter is advanced through the femoral artery and into the renal artery. During catheter placement, the microneedles remain retracted within radiopaque guide tubes, enabling fluoroscopic confirmation of catheter positioning and 3-point wall apposition prior to delivery of therapy.
Once positioning and 3-point wall apposition has been confirmed, all three micro-needles are deployed simultaneously for controlled delivery of therapy into the perivascular space. Targeted infusion of a neurolytic agent to the perivascular space facilitates deep radial and circumferential distribution of therapy.
In addition to having the potential for more complete denervation, the Peregrine approach is expected to further support favorable health economics:
- Procedure may be performed under standard PCI/PTA sedation protocols
- Procedure times and staffing requirements are comparable to routine PCI/PTA
- No capital equipment required
To learn more about the potential benefits of Ablative Solutions’ novel approach, please visit Publications
Ablative Solutions is committed to robust clinical research to further substantiate the procedural, clinical, and health-economic benefits of the Peregrine Catheter for the treatment of hypertension.
The Peregrine Catheter was subject to rigorous pre-clinical studies to ensure the safety of the device and to validate the mechanism of action through tissue norepinephrine (NE) concentration studies and histological examination of the depth and area of denervation.
Based on the safety data collected from the early clinical studies conducted outside the United States, the CE Mark was obtained for the treatment of hypertension. There is a requirement to obtain additional safety and efficacy data in the Post-Market study. This Post-Market Study is currently open for enrollment in EU.
Ablative Solutions’ clinical studies in Europe include:
- Controlled clinical study – enrollment now closed (NCT02155790)
- Post-market study – currently enrolling (NCT02570113)
- TARGET BP I – In the submission phase (NCT02910414)
If you are interested in enrolling patients in the post-market study and would like more information on requirements to become a qualified site, please contact: Clinical-EU@ablativesolutions.com