FDA BRIEF: Week of April 11, 2016
HeartLight® Catheter
HeartLight® Endoscope
HeartLight® Balloon Fill Media
CardioFocus Inc., Marlborough, MA, USA
INDICATION: Endoscopic Ablation System for the treatment of drug refractory recurrent symptomatic paroxysmal atrial fibrillation (AF)
UNMET NEED:
- Approved catheter ablation tools: ThermoCool (J&J), TactiCath (St. Jude Medical)
- Need for device to allow electrophysiologists use direct visual guidance while in the pulmonary veins (PV)
REG PATHWAY: PMA
DEVICE DESCRIPTION:
- System consists of Catheter, Endoscope and Balloon Fill Media, and a console
- Multi-lumen Catheter with inflatable, compliant Balloon at the distal end, Lesion Generator that delivers light energy, Optical fibers for illuminating tissue to permit visualization by Endoscope
EFFECTIVENESS:
- Single prospective, randomized, controlled, open-label, multicenter U.S. investigation, n=366, HeartLight System vs. ThermoCool ablation catheter
- Primary Endpoint: Freedom from documented symptomatic AF occurrence of at least 60 seconds occurring after the 90-day blanking period – 61.1% vs. 61.7%, p=0.003, met prespecified non-inferiority margin of 15% for effectiveness and 8% for safety
- Favorable outcome for Secondary endpoints: Success in isolating all attempted PVs acutely, Chronic Durable PV Isolation , Recurrence of Asymptomatic AF
- Upon completion of the ablation procedure, electrical PV isolation was achieved in the vast majority of the clinically relevant PVs (97.3%)
- No gender discrepancy in primary effectiveness success
- Operator Learning Curve with the use of the system for PV isolation
SAFETY:
- Phrenic nerve injury resulting in diaphragmatic paralysis was more frequent
- PV stenosis (> 50% narrowing) less frequent
- Complication rates greater female subjects; post approval study in female subjects warranted to further evaluate safety profile
Cheatham Platinum (CP) Stent System
Covered CP Stent
Mounted CP Stent
Covered Mounted CP Stent
BiB Stent Placement Catheter
NuMed Inc., Hopkinton, New York, USA
INDICATION: Treatment of native and/or recurrent coarctation of the aorta involving the aortic isthmus or first segment of the descending aorta where there is adequate size and patency of at least one femoral artery
REG PATHWAY: PMA
DEVICE DESCRIPTION:
- System includes bare or covered CP Stent and a delivery catheter (BIB)
- Each stent is balloon expandable and intended for permanent implant
EFFECTIVENESS:
- COAST: Did not meet performance goal of eduction in the systolic blood pressure gradient, length of hospital stay; however,patients achieved complete obliteration of the pre-procedural blood pressure gradient
- COAST II: Improvement in aortic wall injury and/or aortic arch obstruction based on level of severity as well as evaluation of aortic wall injury and/or aortic arch obstruction at Grade 4 or above at 12 months with no clinical worsening.
- All patients derived initial benefit; by 24 months 93% had shown either no change or improvement in Severity of Illness grade vs. baseline
SAFETY:
- Suitable for long-term implant
- Reduces the proportion of patients with serious and somewhat serious adverse events when compared to surgical intervention.
- No uncontained aortic tears,large aneurysms or pseudo-aneurysms
- All new aortic wall injuries successfully repaired by covered stent implantation