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Nanostim™ Leadless Pacemaker

This device is commercially available for use in select international markets.

No Lead. No Pocket. No Compromise.

We are proud to introduce the Nanostim™ leadless pacemaker, the world’s first, commercially available leadless pacemaker and one that is designed to be repositioned or retrieved if needed. For the past 40 years the therapeutic promise of leadless pacing has been discussed, but until now, no one has been able to overcome the technical challenges. Today, St. Jude Medical, the company that delivered the world’s first cardiac pacemaker in 1958, is once again demonstrating how we transform challenges into revolutionary healthcare solutions.
Nanostim
Overview

How will leadless pacing revolutionize your practice?

No lead is required for the Nanostim™ leadless pacemaker, which is small enough to fit entirely inside the right ventricle and is designed for retrievability. When you no longer have to implant leads, you eliminate the known risks of acute lead dislodgement, lead failure, lead removal, and the hemodynamic impact of the lead crossing the tricuspid valve.

Plus, with the elimination of the surgical pocket that traditionally holds the pacemaker and lead, the result is no visible device and subsequent scar. In addition, your patient’s risk for decreased mobility restrictions due to the lead and pocket discomfort is eliminated. The Nanostim leadless pacemaker comes with a 10 year warranty and may last longer depending on your pacing needs.

When you implant a device that eliminates leads and the surgical pocket, you can deliver therapy without compromise.

How does leadless pacing longevity compare to standard solutions?

With the Nanostim leadless pacemaker, you do not need to compromise on longevity. The Nanostim leadless pacemaker comes with the same St. Jude Medical 10-year warranty as our traditional single-chamber devices.


The device is also designed for:

Longevity
  • 10-year warranty
  • High-capacity battery
  • Proprietary electrode with steroid
  • Industry-leading electronic circuit
  • Novel low-power communication
Implantability
  • 18 F sheath 
  • Double fixation mechanism 
  • Radiographic indicator 
  • Intuitive ergonomic handle 
  • Tether/testing mode 
  • Repositionable
Retrievability
  • Designed for capture, torque, removal and replacement
  • Seamless, polished titanium housing
  • Retrieval catheter
  • Metal-to-metal docking button and retrieval tools
  • High torque factor

MATERIALS & LINKS

How it Works

How does leadless pacing work?

We designed the Nanostim leadless pacemaker for easy deployment and retrieval. The Nanostim™ leadless pacemaker is delivered using an 18 F introducer via the femoral vein and is placed into the right ventricle. This VVIR pacemaker attaches with a dual fixation system and paces the heart using a St. Jude Medical steroid-eluting electrode. If the implanter is not satisfied with pacing parameters, the device can be repositioned with the delivery catheter.

The Nanostim leadless pacemaker is designed for retrievability if the need arises. This is facilitated by a docking port that mates to our retrieval catheter, allowing the operator to apply enough torque to safely remove the device.

Programming

We understand how important simplified programming and follow-up care are to your practice. We designed the world’s first CE-marked leadless pacemaker to be compatible with the St. Jude Medical Merlin™ Patient Care System (PCS). To further support your workflow, our Nanostim™ Link software also uses the same user interface as St. Jude Medical programming software.

View Sponsored Video

Percutaneous In Vivo Placement of a Novel Intracardiac Leadless Pacemaker:
Results From The First-in-man Leadless Study
Vivek Y. Reddy, MD
Heart Rhythm Society 2013


MATERIALS & LINKS

Retrievability

Designed for retrievability

 

Seamless, Polished Titanium

This seamless, polished titanium housing is non-porous and completely washed in the cardiac cycle. Chronic animal studies have demonstrated that the device does not encapsulate like a traditional lead.

Easy to Capture, Torque and Remove

The docking button offers simplified capture and the retrieval tools feature a metal-to-metal interface that allows the user to apply a high torque factor compared to traditional lead extraction.

Preclinical Results: Retrieval Safety1

Preclinical study in 10 sheep:

  • Implant duration > 5 months (range 159-161 days)
  • 100% successful LP retrieval
  • Average time from retrieval catheter insertion to removal of LP 2 minutes 35 seconds (range 1-4 minutes)
  • Average delivery time for re-implantation from delivery catheter 2 minutes 42 seconds (range: 2-3 minutes) with 100% success (n=5)
  • No embolization
  • No dislodgement
  • No perforations

Average Time
Snare 1 minute 48 seconds
Retrieval 2 minutes 35 seconds

Nanostim Retrieval Chart

References

1 Sperzel J, Khairkhahan A, Ligon D, Zaltsberg S. Feasibility, efficacy and safety of percutaneous retrieval of a leadless cardiac pacemaker in an in vivo ovine model. Europace 2013; 15(Suppl 2):859.

Economic & Clinical Facts

 

Economic & Clinical Facts

More than four million people around the world have an implanted pacemaker or other cardiac rhythm management device, and 700,000 additional patients receive an implant every year. Although the incidence of pacemaker complications is relatively low, the magnitude of the device patient population means that these events can have a major economic impact on the clinic and healthcare system. They also have a serious impact on the patient’s quality of life.

Bacterial infection is responsible for the majority of implantable pulse generator (IPG) complications, and the increase in admissions for pacemaker infections is growing at twice the rate than the pacemaker implantation growth rate1, 2

This increased rate of infection is likely due to2

  • More patient comorbidities
  • Longer procedures
  • More resistant S aureus and coagulase (-) Staphylococcus species (eg, S epidermidis)

 

The chances of developing an implantable pulse generator (IPG) infection increases based on the type of procedure being performed, and the patients’ medications and characteristics.

The Burden of IPG Infections

  • The in-hospital mortality rate for a pacemaker infection is 8.4%, and the 15 month post-implant mortality rate for pacemaker patients with an infection is 36.3%, more than double the 15.4% mortality rate of uninfected pacemaker patients.14
  • Average hospital length of stay (LOS) for a pacemaker patient with an infection is 14.4 days, compared to 4.8 days for patients without an infection.15
  • In the U.S., the incremental cost of treating a pacemaker patient with an infection ranges from $16,852 to $24,459.16
  • In Germany, the cost of treating an infected pacemaker patient is €7,09117
  • Effective October 1, 2012, Medicare and Medicaid do not reimburse hospitals for IPG infections acquired during a hospital stay18

Clinical Facts

Pacemaker Complications Frequency
Lead dislodgement 2.2% to 3.7%3
Pneumothorax (80% require chest tube)  1.6% to 2.6%4,5,6,7
Severe venous thrombosis 1% to 3%4,5,6,7
Chronic lead failure 2% to 4%4,5,6,7
Single chamber infection rate (de novo) 1%6,7,8
Pacemaker infection rate (replacement) 1% to 2%9
Skin erosion 0.8%10
Device migration 2% to 4%11,12
Pocket hematoma (prolonged hospitalization/reoperation) 2% / 1%13
Note: Catheter ablation procedures, which utilize a femoral artery approach, may result in vascular complications such as femoral pseudoaneurysms or groin hematomas at rates between 0.93%9-2.4%.10 These ablation catheters used in EP procedures typically use smaller-sized introducers for access (≤8.5F).

References

1 Voigt et al. J Amer Coll Cardiol. 2006;48(3):590-591.

2 Voigt et al. PACE 2010;33(4):414-419.

3 Pakarinen S, Oikarinen L, Toivonen L. Short-term implantation-related complications of cardiac rhythm management device therapy: a retrospective single-centre 1-year survey. Europace 2010;12(1):103-108.

4 Klutstein M, Balkin J, Butnaru A, et al. Tricuspid incompetence following permanent pacemaker implantation. Pacing Clin Electrophysiol 2009;32(Suppl 1):S135-137.

5 Borek PP, Wilkoff BL. Pacemaker and ICD leads: strategies for long-term management. J Interv Card Electrophysiol 2008;23(1):59-72.

6 Gul EE and Kayrak M. Common pacemaker problems: lead and pocket complications. In: Modern Pacemakers-Present and Future, ed. Das MK. Available at: http://www.intechopen.com/books/modern-pacemakers-present-and-future/common-pacemaker-problems-lead-and-pocket-complications. Last accessed 23 August 2013.

7 Tischer TS, Hollstein A, Voss W et al. A historical perspective of pacemaker infections: 40-years single-centre experience. Europace 2013. Epub ahead of print 28 June 2013.

8 Herce´ et al. Risk factors for infection of implantable cardiac devices: data from a registry of 2496 patients. Europace (2013) 15, 66–70.

9 Baddour et al. Circulation 2010

10 Kiviniemi et al. Complications Related to Permanent Pacemaker Therapy. Volume 22, Issue 5, Article first published online: 30 JUN 2006.

11 Kuhlkamp V et al. J Am Coll Cardiol. 2002;39(5):790-797.

12 Thomas AC et al. Pacing Clin Electrophysiol. 1988;11:2053-2058.

13 Wiegand et al. Pocket Hematoma After Pacemaker or Implantable Cardioverter Defibrillator Surgery. CHEST 2004; 126:1177–1186.

14 Sohail et al. Archives of Internal Medicine. 2011;171(20):1821-1828

15 Sohail et al. Archives of Internal Medicine. 2011;171(20):1821-1828

16 Ferguson et al. The additional hospital costs generated in the management of complications of pacemaker and defibrillator implantations, The Journal of Thoracic and Cardiovascular Surgery, Volume 111, Issue 4, April 1996, Pages 742-752.

17 Kuehn et al. Economic implications of infections of implantable cardiac devices in a single institution. European Journal of Cardio-thoracic Surgery 37 (2010) 875—879.

18 CMS IPPS Final Rule for FY2013 
 


MATERIALS & LINKS

Tech Specs

Nanostim™

Leadless Pacemaker (LP) and Delivery System Catheter
Ordering Information   View Catalog   

Contents: Leadless Pacemaker and Delivery System Catheter

Reorder Number Description Length (mm) Outer Diameter (mm) Weight (g) Volume (cc) Recommended Introducer Size (F) Deflection (degrees) Outer Diameter of Sheath (mm [inch]) Working Length (cm)
S1DLCP Leadless Pacemaker / Delivery System Catheter 41.4 / - 6 / - 2 / - 1 / - - / 18 - / >180° - / 4,6 (.178) - / 128

Nanostim™ Introducer Kit

Ordering Information   View Catalog   

Contents: Nanostim™ Introducer and Dilator

Reorder Number Description Sheath French Size Inner Diameter of Sheath (mm [inch]) Working Length (cm)
S1S18F Introducer / Dilator 18 F / - 6,4 (.252") / 1,0 (.039") 30 (11.8") / 43 (16.9")

Nanostim™ Retrieval Catheter

Single Loop Snare
Ordering Information   View Catalog   

Contents: Retrieval Catheter and Single Loop Snare

Reorder Number Description Sheath French Size Loop Diameter (mm) Outer Diameter of Sheath (mm [inch]) Working Length (cm)
S1RSIN Nanostim™ Retrieval Catheter and Single Loop Snare 18 F 19 (.748") 4,6 (.181") 128

Nanostim™ Retrieval Catheter

Triple Loop Snare
Ordering Information   View Catalog   

Contents: Retrieval Catheter and Triple Loop Snare

Reorder Number Description Sheath French Size Loop Diameter (mm) Outer Diameter of Sheath (mm [inch]) Working Length (cm)
S1RTRI Nanostim™ Retrieval Catheter and Triple Loop Snare 18 F 20 (.787") 4,6 (.181") 128

Nanostim™ Programmer Link

Ordering Information   View Catalog   

Contents: Programmer Link, Programmer Accessories

Reorder Number Description
S1LINK Programmer Link delivered with Patient Cable, USB Cable, Link Mount for Merlin™ PCS, power supply and plug kit
3626 5-Lead ECG Patient Cable

Indications, Safety & Warnings
Print

Indications
The Leadless Pacemaker is indicated for:
Chronic atrial fibrillation with 2 or 3° AV or bifascicular bundle branch block (BBB),
Normal sinus rhythm with 2 or 3° AV or BBB block and a low level of physical activity or short expected lifespan, or
Sinus bradycardia with infrequent pauses or unexplained syncope with EP findings.

Contraindications
Use of any pacemaker in patients with a co-implanted ICD is contraindicated because high-voltage shocks could damage the pacemaker, and the pacemaker could reduce shock effectiveness.
Single-chamber ventricular demand pacing is relatively contraindicated in patients who have demonstrated pacemaker syndrome, have retrograde VA conduction, or suffer a drop in arterial blood pressure with the onset of ventricular pacing.
Programming of rate-responsive pacing is contraindicated in patients with intolerance of high sensor-driven rates.
Use of a leadless pacemaker could involve higher levels of risks, compared to those of conventional pacemakers, due to inadvertent pulmonary embolism of the pacemaker in patients also presenting with elevated right-ventricular pressure or reduced pulmonary reserve.
Use in patients with an implanted vena cava filter or mechanical tricuspid valve is contraindicated because of interference between these devices and the delivery system during implantation.
Use is contraindicated in patients who are expected to be hypersensitive to a single dose of 0.7 milligrams of dexamethasone sodium phosphate.

Devices depicted may not be available in all countries. Check with your St. Jude Medical representative for product availability in your country.

Rx Only.
Please review the Instructions for Use prior to using these devices for a complete listing of indications, contraindications, warnings, precautions, potential adverse events and directions for use.
Product referenced is approved for CE Mark.

NanostimTM leadless pacemaker is designed, developed and manufactured by St. Jude Medical.

Last Updated: 13 February 2014