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) (Figure 16). 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.

Side Effects/Potential Complications

The following adverse effects could possibly occur as a result of the use of the Peregrine System^TM Infusion Catheter: Bleeding requiring intervention, death, embolism (air, foreign body, plaque, thrombus), hematoma (including access site), infection (i.e. sepsis, access site infection), pseudoaneurysm, vessel dissection, vascular occlusion, vascular stenosis, vascular aneurysm, vascular spasm, vessel perforation requiring intervention (including access site), vessel rupture (including aneurysm), anticoagulant related hemorrhage.

Warnings and Precautions

Avoid treating patients with the following conditions:

-Patients with bleeding disorders (such as bleeding diathesis, thrombocytopenia and severe anemia);

-Calcification at the site of needle deployment;

-Anatomical abnormalities 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 severe or life-threatening allergy to contrast media;

-Pregnancy and or lactating;

-Children;

-Patients known to have a non-functioning kidney;

• The Peregrine System^TM Infusion Catheter has not been evaluated in children or in pregnant or lactating women.
• The Peregrine System Infusion Catheter has not been evaluated for use in the neurovasculature.
• Do not use the device if it has been damaged in any way. Do not use if the Peregrine System^TM Infusion Catheter is kinked or occluded.  Damaged devices may lead to vessel rupture or needle detachment.
• Do not deploy Peregrine System^TM Infusion Catheter guide tubes and needles at a target site that is within 1 mm of a branch or within 4 mm of the ostium.
• Peregrine System^TM Infusion Catheters are supplied STERILE using an ethylene oxide (EO) process and are non-pyrogenic and are not made with natural rubber latex. Do not use if sterile barrier is damaged or package is opened.  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.
• The Peregrine System^TM Infusion Catheter has not been evaluated for use in the neurovasculature.
• When the Peregrine System^TM Infusion Cathteter is exposed to the vascular system, it should be manipulated while under high-quality fluoroscopic observation. Do not advance or retract the catheter if resistance is met during manipulation, determine the cause of the resistance before proceeding.
• The Peregrine System^TM Infusion Catheter should be used only by physicians trained in percutaneous procedures.