FDA BRIEF: Week of April 11, 2016

FDA approved

 

heartlight

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

KM Curve

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

stent

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
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