Nebraska teenager Shelbi Klingsporn

World's Smallest Pacemaker will be Tested in Space

A high school student’s personal inspiration leads to a high-flying science project.

A Nebraska teenager’s science project will soon take one of healthcare’s most innovative products into space.

17-year-old Shelbi Klingsporn’s idea – to test the effects of high radiation and low temperatures on the world’s smallest pacemaker during spaceflight – will liftoff from NASA’s facility in Virginia on June 22. The inspiration for her project was personal. 

Shelbi Klingsporn

Shelbi Klingsporn

"I had to get out of my comfort zone and ordinary thinking."

Shelbi knows more than most teenagers about pacemakers, because one of her friends needed one at an early age. So after reading about Micra, the new miniaturized pacemaker made by Medtronic, Shelbi launched her idea.

As part of a school assignment, she submitted a proposal to Cubes in Space, a private education program that, in partnership with NASA, encourages educators around the world to engage students in science and space exploration. Students submit technical diagrams and written proposals explaining why their experiment should be launched into space. “I had to get out of my comfort zone and ordinary thinking. I had to be unique and the teachers really encouraged me,” Shelbi said.

Shelbi and her teachers reached out to Medtronic, and several members of the Micra team gave her advice and background information about the device. “They were a terrific help,” she said.


"I've had the chance to do a lot of interesting things at Medtronic, but putting Micra on a rocket is definitely a highlight."

Wade Demmer, senior program manager


Wade Demmer

Wade Demmer, senior project manager

"The idea that we might learn something that could impact the future of medical device development is very exciting.”

Learning Opportunity for Medtronic

The experiment will stretch testing boundaries for Medtronic, said senior program manager Wade Demmer. Vibrations during the rocket flight are “worse than a paint shaker,” Demmer said, and the landing could be rough. But, the Medtronic team hopes Micra will still function after the flight and engineers will thoroughly examine it afterward to see what they can learn. “This is a once-in-a-lifetime learning opportunity for us,” Demmer said. “The flight conditions go beyond what we test for on Earth. The idea that we might learn something that could impact the future of medical device development is very exciting.”

Micra is roughly the size of a vitamin pill

Micra pacemaker

Why Micra? The experiment must fit into a 4x4x4 centimeter cube for the approximately ten-minute flight. Micra, which is 93 percent smaller than conventional pacemakers and about the size of a large vitamin, is small enough to fit inside the cube. Cubes in Space picks up to 80 winners, which are launched every year into space on board a NASA sounding rocket.

Shelbi, along with her science and English teachers from the Valley Alternative Learning Transitioning School in Scottsbluff, Nebraska, will attend the launch in Virginia. Shelbi will give a presentation about her experiment on Wednesday, June 21 at the NASA facility. Liftoff is currently scheduled to happen between 5:30 and 8:30 AM on Thursday, June 22. You can watch it live, courtesy of NASA.


IMPORTANT SAFETY INFORMATION: MICRA TRANSCATHETER PACING SYSTEM VVIR SINGLE CHAMBER WITH SURESCAN MRI

Indications

Micra Model MC1VR01 is indicated for patients with:

  • symptomatic paroxysmal or permanent high grade AV block in the presence of AF,
  • symptomatic paroxysmal or permanent high grade AV block in the absence of AF, as an alternative to dual chamber pacing when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy,
  • symptomatic bradycardia-tachycardia syndrome or sinus node dysfunction (sinus bradycardia/sinus pauses), as an alternative to  atrial or dual chamber pacing when atrial lead placement is considered difficult, high risk, or not deemed necessary for effective therapy.

Rate-responsive pacing is indicated to provide increased heart rate appropriate to increasing levels of activity.

Contraindications

Micra model MC1VR01 is contraindicated for patients who have the following types of medical devices implanted: an implanted device that would interfere with the implant of the Micra device in the judgment of the implanting physician, an implanted inferior vena cava filter, a mechanical tricuspid valve, or an implanted cardiac device providing active cardiac therapy that may interfere with the sensing performance of the Micra device.

The use of deactivated Micra devices in situ and an active Micra device, or an active transvenous pacemaker or defibrillator, has not been clinically tested to determine whether EMI or physical interaction is clinically significant. Bench testing supports that implantation of an active Micra device, or an active transvenous pacemaker or defibrillator, next to an inactivated Micra device is unlikely to cause EMI or physical interaction. post-approval studies are planned to characterize risks of co-implanted, deactivated Micra devices. Currently recommended end of device life care for a Micra device may include the addition of a replacement device with or without explantation of the Micra device, which should be turned off.

The device is contraindicated for patients who have the following conditions: femoral venous anatomy unable to accommodate a 7.8 mm (23 French) introducer sheath or implant on the right side of the heart (for example, due to obstructions or severe tortuosity), morbid obesity that prevents the implanted device from obtaining telemetry communication within ≤12.5 cm (4.9 in), or known intolerance to the materials listed in the Instruction for Use, or to heparin, or sensitivity to contrast media that cannot be adequately premedicated, or where a single dose of 1.0 mg dexamethasone acetate may be contraindicated.

Precautions should be taken before administering anticoagulant agents, antiplatelet agents, or contrast media in patients with known hypersensitivity to these agents.

The following may be contraindications to Micra VVIR pacing. Rate-responsive mode may be contraindicated for patients who cannot tolerate pacing rates above the programmed Lower Rate. Asynchronous VVIR pacing with sinus rhythm may be contraindicated when competitive pacing is considered undesirable or causes symptoms of pacemaker syndrome. The patient’s age and medical condition should be considered by physicians and patients as they select the pacing system, mode of operation, and implant technique best suited to the individual.

Warnings and Precautions

End of Service (EOS) – When the EOS condition is met, the clinician has the option of permanently programming the device to Off and leaving it in the heart, or retrieving the device, provided the device has not yet become encapsulated.  Removal of the Micra device after it has become encapsulated may be difficult because of the development of fibrotic tissue. If removal of the device is required, it is recommended that the removal be performed by a clinician who has expertise in the removal of implanted leads.

MRI conditions for use – Before an MRI scan is performed on a patient implanted with the Micra device, the cardiology and radiology professionals involved in this procedure must understand the requirements specific to their tasks as defined in the device manuals.

Potential Complications

Potential complications include, but are not limited to, toxic/allergic reaction, oversensing, acceleration of tachycardia, myocardial infarction and surgical complications such as cardiac perforation, pericardial effusion, cardiac tamponade, death, device embolization, access site hematoma and AV fistulae, vessel spasm, infection, inflammation, and thrombosis.

See the device manuals for detailed information regarding the implant procedure, indications, contraindications, warnings, precautions, MRI conditions for use,  and potential complications/adverse events. For further information, please call Medtronic at 1-800-328-2518 and/or consult Medtronic’s website at www.medtronic.com.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.