Performance Information

The Peregrine System Infusion Catheter has been the subject of several clinical studies, including 3 open label studies and two randomized controlled studies. Collectively, these studies showed that the Peregrine Catheter, when used in combination with a neurolytic agent, can reduce blood pressure in hypertensive patients. The following published results from the two randomized controlled studies, Target BP OffMed and Target BP I, are summarized below.

• The 1-year study results from the randomized, blinded, sham-controlled, proof-of-concept, TARGET BP OFF-MED study showed at 8 weeks post-procedure, a mean (±SD) 24-hour systolic BP change of -2.9 ± 7.4 mmHg (p=0.009) versus -1.4 ± 8.6 mmHg (p=0.25) in the RDN and sham groups, respectively (mean between group difference: 1.5 mmHg; p=0.27). ¹ There were no differences in safety events between groups. After 12 months of blinded follow-up, with medication escalation, patients achieved similar office systolic BP (RDN: 147.9 ± 18.5 mmHg; sham: 147.8 ± 15.1 mmHg, p=0.68) with significantly lower medication burden in the RDN group (mean daily defined dose; 1.5 ± 1.5 versus 2.3 ± 1.7; p=0.017).
• In the TARGET BP I study, 301 patients were randomized to RDN using the Peregrine catheter (n=148) or sham control (n=153). At 3 months post-procedure, the primary endpoint was met.² There was a greater reduction in 24-hour ambulatory SBP observed in the RDN group (-10.0 ± 14.2 mmHg) relative to the sham group (-6.8 ± 12.1 mmHg), with a significant difference between treatment groups favoring RDN (-3.2 mmHg, 95% CI -6.3 to 0.0; p=0.0487). Alcohol-mediated RDN was associated with favorable procedural performance and intermediate-term safety.

 

1 Pathak A, Rudolph UM, Saxena M, et al. Alcohol-mediated renal denervation in patients with hypertension in the absence of antihypertensive medications. EuroIntervention. 2023;19(7):602- 611

2 Kandzari DE, Weber MA, Pathak A, et al. Effect of alcohol-mediated renal denervation on blood pressure in the presence of antihypertensive medications: primary results from the TARGET BP I randomized clinical trial. Circulation. 2024

 

Safety Information

The following information is from the Peregrine System Infusion Catheter package insert.

The Peregrine System Infusion Catheter is contraindicated in patients who are allergic or intolerant of the neurolytic agent.

The Peregrine System Infusion Catheter may be associated with the following side effects / complications when used as intended: acute and chronic renal failure, acute kidney injury (AKI), angina, arrhythmia, bleeding requiring intervention, cardiogenic shock, death, embolism (air, foreign body, plaque, thrombus), hematoma (including access site), infection (i.e. sepsis, access site infection), myocardial infarction, nerve injury, neurovascular events such as cerebrovascular accident (CVA) or transient ischemic attack (TIA), pain, pseudoaneurysm, renal artery aneurysm, renal artery stenosis, respiratory failure, septic shock, vessel dissection, vessel occlusion (including renal artery occlusion), vessel perforation requiring intervention (including access site), vessel rupture (including aneurysm), vessel tear. The following adverse effects could possibly occur as a result of delivering a neurolytic agent: pain (back pain or abdominal pain), vagal bradycardia, hypotension, renal failure and renal insufficiency.

The Peregrine System Infusion Catheter has the following warnings and precautions:

• Do not use the device if it has been damaged in any way. Do not use if the Peregrine System™ Infusion Catheters are kinked or occluded. Damaged devices may lead to vessel rupture or needle
• Carefully read all instructions prior to use.
• Avoid treating patients with the following conditions:
  • Patients who do not tolerate antiplatelet /anticoagulant therapy;
  • Patients with bleeding disorders (such as bleeding diathesis, thrombocytopenia and severe anemia);
  • Calcification at the site of needle deployment;
  • Anatomical abnormalities of the renal artery, including: aneurysms, severe stenosis, excessive tortuosity that preclude a safe insertion of the guiding catheter;
  • Target vasculature diameter less than Ø3 mm or larger than Ø7 mm;
  • Target vasculature length less than 5 mm in length;
  • Patient has a known allergy to contrast media;
  • Pregnancy and or lactating;
  • Children;
  • Single kidney;
  • Chronic atrial fibrillation;
  • Significant chronic cardiac failure;
  • Recent stroke;
  • Myocardial infarction
  • Unstable angina;
  • Patients on immunosuppressive medications or immunosuppressive doses of steroids;
  • Previous renal artery angioplasty associated with stenting or other implants in the target vasculature;
  • Patients known to have a non-functioning kidney;
  • Patient known to have a renal transplant;
  • Patients with Type 1 diabetes.

If the neurolytic agent is alcohol:

• Do not draw into the syringe until ready to perform the infusion.
• Do not leave the alcohol in the syringe more than 15 minutes.
• Precautions, such as wearing protective eyewear and gloves, should be taken to avoid exposure to skin and eyes, as it will cause irritation.
• For exposure to skin or eyes, flush with copious quantities of water for 15 minutes and seek medical advice.
• Precautions, such as wearing a facemask, should be taken when handling dehydrated alcohol to avoid inhalation of vapors, as it will cause respiratory tract irritation.
• For exposure to alcohol vapors, move the person to fresh air, remove contaminated clothing and seek medical advice.

 

Do not deploy Peregrine Catheter guide tubes and needles at a target site that is within 1 mm of a branch or within 4 mm of the ostium.

Do not infuse the neurolytic agent unless there is angiographic or fluoroscopic confirmation of correct positioning of the device and infusion needles.

 

Do not move the catheter while the needles or the guide tubes are deployed.

 

During infusion of the neurolytic agent, if resistance is felt while pushing the syringe plunger, stop the infusion, retract the needles and guide tubes, remove the catheter and inspect.

 

A thorough understanding of the technical principles, clinical applications and risks associated with percutaneous transluminal catheterization is necessary before using this device.

 

If alcohol is chosen as the neurolytic agent, volumes of 0.3 mL and 0.6 mL per renal artery have been evaluated in clinical trials. In preclinical studies, volumes from 0.15 mL to 0.6 mL per renal artery have been evaluated.

 

Peregrine System™ Infusion Catheters are supplied STERILE using an ethylene oxide (EO) process, are non-pyrogenic and are not made with natural rubber latex.  Do not use if sterile barrier is damaged or package is opened.

 

The Peregrine System™ Infusion Catheters are intended for single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity and/or sterility of the device, leading to patient injury.