PUNCTUA™ Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Overview

The PUNCTUA CRT-D offers physicians demonstrated performance with key device features that patients care about most – the smallest, thinnest, long‐lasting high‐energy devices in the world.1

Product Details

Hear what patients are saying about size, shape, longevity and appropriate therapy.

Small. Thin. Long-lasting.

The smallest, thinnest high‐energy devices in the world at 9.9 mm thin and 31.5 cc, PUNCTUA CRT-Ds offer patients advanced therapy in a small device. Not only are PUNCTUA devices small, they feature proprietary battery technology which is projected to last, on average, twice as long as competitive devices.2

Appropriate Therapy

T-wave oversensing remains the most frequent cause of ventricular oversensing for the industry; however shocks due to T-wave oversensing occur in <0.05% of shocks with Boston Scientific devices. 3,4 PUNCTUA’s bandpass filter (20–85 Hz) is designed to filter out low frequency T‐waves and high frequency myopotential noise.

PUNCTUA also features rate‐based rhythm discriminators that have long been an industry standard.

A Legacy of Lead Reliability

ENDOTAK® RELIANCE is the only lead with GORE ePTFE‐covered shocking coils, which prevent tissue in‐growth and does not affect defibrillation thresholds. The RELIANCE DF-1 lead has nearly 98.9% survival probability at 9 years while Medtronic Sprint Quattro™ has 98.4% at 5 years and St. Jude Riata™ ST Optim™ has 98.8% at 3 years.5

Advanced Heart Failure Management

Heart failure is the #1 leading cause of hospitalizations in the developed world. Boston Scientific is the only company with indications for all four classes of heart failure. Through LATITUDE® Heart Failure Management, Boston Scientific brings you the only remotely monitored diagnostic information aligned with JCAHO and the ACC/AHA guidelines for heart failure.

LATITUDE Heart Failure Management System is the only remote monitoring system that has been approved with a weight alert that indicates a potential change in a patient’s health status. The essential diagnostic information gained through remote monitoring of weight and blood pressure (LATITUDE® Heart Failure Management) is now included with PUNCTUA devices.

3) Powell B, Cha Y-M, AsirvathamS, et al. Noise and oversensing-related inappropriate ICD shocks diagnosed with remote monitoring: the ALTITUDE EGM STUDY. Heart Rhythm.2010;7[May Supplement]:AB04-4.
4) AsirvathamS, Powell B, Cha Y, et al. Europace. 210;12;86.2
5) Results based on publicly available data for dual coil, active fixation ICD leads, as reported by each individual company in their product performance report.
  • Boston Scientific Q2 2011 Product Performance Report – data current as of Apr. 8, 2011
  • St. Jude Medical April 2011 Product Performance Report – data current as of Dec. 31, 2010
  • Medtronic 1st Edition CRDM PPR 2011 Issue 64 – data current as of Jan. 31, 2011
  

CRM-46303-AA

1 - When compared to competitive devices
2 - Not intended to replace longevity estimates. Analysis of aggregate LATITUDE Patient Management system data from over 67,000 patients as of August 9th, 2011. Data on file.

  • Individual symptoms, situations, circumstances, and results may vary. This information is not intended to be used for medical diagnosis or treatment or as a substitute for professional medical advice.
  • Device programming was determined by physicians. Accordingly, the aggregate average represents a mean value that is based upon real‐world programming.
  • The data reflect projected longevities based upon parameter settings, rather than observed performance.
  • This information is a defined data set and could change in the future.
  • The low variability may be the result of the devices still being quite young. As the devices continue to age, patient differences in pacing and other factors may cause greater variability in the Approximate Time to Explant.
  • The LATITUDE data are assumed to be representative of the general patient population.
  • The distribution is non‐normal; therefore the standard deviation must be interpreted with care. It may not necessarily be true that ~95% of the data lie within 2 standard deviations of the mean, ~99.7% within three, etc.

Prescriptive Information

Potential Adverse Events

Potential adverse events include, but are not limited to, the following: allergic/physical/physiologic reaction, death, erosion/migration, fibrillation or other arrhythmias, lead or accessory breakage (fracture/insulation/lead tip), hematoma/seroma, inappropriate or inability to provide therapy (shocks/pacing/sensing), infection, procedure related, and component failure. Patients may develop psychological intolerance to a pulse generator system and may experience fear of shocking, fear of device failure, or imagined shocking. In rare cases severe complications or device failures can occur.
Refer to the product labeling for specific indications, contraindications, warnings/precautions and adverse events. Rx only.
(Rev. P)

Contraindications

There are no contraindications for this device.

CRT-D Systems and Leads from Boston Scientific CRM


Indications and Usage
These Boston Scientific Cardiac Resynchronization Therapy Defibrillators (CRT-Ds) are indicated for patients with heart failure who receive stable optimal pharmacologic therapy (OPT) for heart failure and who meet any one of the following classifications:
  • Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms
  • Left bundle branch block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure

Do not use atrial-only modes in patients with heart failure. LV lead dislodgment to a position near the atria can result in atrial oversensing and LV pacing inhibition. Physicians should use medical discretion when implanting this device in patients who present with slow VT. Do not kink leads. Do not use defibrillation patch leads with the CRT-D system. Do not use this pulse generator with another pulse generator. For specific models, when using a subpectoral implantation, place the pulse generator with the serial number facing away from the ribs.

For DF4-LLHH or DF4-LLHO leads, use caution handling the lead terminal when the Connector Tool is not present on the lead and do not directly contact the lead terminal with any surgical instruments or electrical connections such as PSA (alligator) clips, ECG connections, forceps, hemostats, and clamps. Do not contact any other portion of the DF4-LLHH or DF4-LLHO lead terminal, other than the terminal pin even when the lead cap is in place.

Warnings

Read the product labeling thoroughly before implanting the pulse generator to avoid damage to the system.. Such damage can result in patient injury or death. For single patient use only. Do not reuse, reprocess, or resterilize. Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness, or death. Reuse, reprocessing, or resterilization may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness, or death of the patient. Program the pulse generator Tachy Mode to Off during implant, explant or postmortem procedures. Always have sterile external and internal defibrillator protection available during implant. Ensure that an external defibrillator and medical personnel skilled in CPR are present during post-implant device testing. Advise patients to seek medical guidance before entering environments that could adversely affect the operation of the active implantable medical device, including areas protected by a warning notice that prevents entry by patients who have a pulse generator. Do not expose a patient to MRI device scanning.. Do not subject a patient with an implanted pulse generator to diathermy, Do not use atrial-tracking modes in patients with chronic refractory atrial tachyarrhythmias.

Precautions

For specific information on precautions, refer to the following sections of the product labeling: clinical considerations; sterilization, storage and handling; implant and device programming; follow-up testing; explant and disposal; environmental and medical therapy hazards; hospital and medical environments; home and occupational environments. Advise patients to avoid sources of electromagnetic interference (EMI) because EMI may cause the pulse generator to deliver inappropriate therapy or inhibit appropriate therapy.
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