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Finding Balance through Innovation

2013 Medical Innovation Summit

October 14-16, 2013


Top 10 Innovations for 2010

Welcome to the fourth edition of our Top 10 Medical Innovations.

We are pleased to share with you the final results of a rigorous selection process that started many months ago when we asked scores of our clinicians and researchers at the Cleveland Clinic the simple question: "What game-changing medical technology, device, or therapy do you see breaking through in 2010?"

Cleveland Clinic's culture of innovation naturally fosters a good deal of discussion about "hot" new technologies and which ones will have the greatest impact each year. The purpose of our annual "Top 10 Medical Innovations" is to share the perspective of our leaders on what innovations they felt would help to re-shape healthcare in the next year. As you turn the pages and move from innovation #10 through to the #1 selection for 2010, we are certain that you will be amazed by the diversity of these innovations, their unique utility, and by their truly game-changing nature.

#1 Bone Conduction of Sound For Single-Sided Deafness:

A new non-surgical, removable hearing and communication device designed to imperceptibly transmit sound via the teeth to help people with single-sided deafness.
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#1 Bone Conduction of Sound For Single-Sided Deafness:

Single sided deafness (SSD) affects 9 million people in the U.S. The newly developed non-surgical, non-invasive, removable hearing device bypasses this requirement by transmitting sound via the teeth and bones, to both cochleae. This digital audio device is nearly invisible and consists of a small microphone unit worn behind the ear on the deaf side and an easy-to-remove dental retainer-like processor for the conversion of audio signals into vibratory energy.

The world's first non-surgical, non-invasive bone-conduction hearing device received FDA 510(k) clearance in 2011. In addition to SSD, the intended future indications include addressing the needs of patients with conductive, mixed hearing loss and tinnitus, as well as consumer and covert communications.
#2 Low-Volume, Low-Pressure Tracheal Tube Cuff To Reduce Ventilator-Associated Pneumonia:

A device that dramatically reduces the risk of ventilator-associated pneumonia and death in the hospital ICU by providing continuous effective airway seals.
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#2 Low-Volume, Low-Pressure Tracheal Tube Cuff To Reduce Ventilator-Associated Pneumonia:

Ventilator-associated pneumonia (VAP) is the leading cause of hospital-acquired mortality in the ICU and is estimated to result in $1.5 billion in excess expenditure each year. The newly developed endotracheal tube cuff has a special suction setup that provides continuous effective airway seals at low mucosal pressures. It allows all secretions to drain from the subglottic space just above the tube cuff, which dramatically reduces the risk of VAP and death in the hospital ICU.

This device received the 510(k) clearance from FDA in late 2009 and a recent study verified the tube's ability to substantially reduce microaspiration. More physicians are now able to take advantage of this innovative technology to reduce the incidence of VAP and further improve patients' safety.
#3 Continuous-Flow Ventricular Assist Devices:

Tiny 3-ounce devices surgically attached alongside the heart that quietly and effectively take over the pumping ability of the heart.
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#3 Continuous-Flow Ventricular Assist Devices:

The newest version of continuous-flow ventricular assist devices weighs only 3 ounces. It is attached alongside the native heart and runs on rechargeable batteries connected through the abdomen. The new device can quietly and effectively take over the pumping ability of the heart by generating up to 10 liters of blood flow per minute and providing up to 10 years of circulatory support.

This device has earned a CE mark for both bridge-to-transplant and lifetime use and is currently used in the U.S. as a bridge-toheart transplant under FDA-approved clinical investigation. In one study, the continuous-flow pump was equivalent in efficacy and adverse event profile, but outperformed the pulsatile pump in regards to mortality. Third-generation pumps are being developed, which couple continuous-flow rotary devices with a non-contact bearing design.
#4 Non-Vitamin K Antagonist Oral Anticoagulants:

Predictable and well-tolerated alternatives to the oral anticoagulant warfarin that provide a more convenient-and safe-way for patients to dose themselves and prevent blood-clot formation.
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#4 Non-Vitamin K Antagonist Oral Anticoagulants:

Venous thromboembolism (VTE), which is caused by a blood clot, is a serious life threatening condition that affects more than 1 million Americans annually. Two newly developed non-vitamin K antagonist oral anticoagulants, which target the Factor Xa and thrombin respectively, now offer predictable and well-tolerated alternatives to the oral anticoagulant warfarin and can provide a more convenient-and safe-way for patients to dose themselves and prevent blood-clot formation.

Approved for use in Canada and Europe, the Factor X drug was resubmitted for FDA approval in early 2011, while the thrombin drug (dabigatran) received FDA approval in October 2010.
#5 Fertility Preservation Through Oocyte Cryopreservation:

A rapidly-improving technology that allows eggs of a healthy woman to be safely frozen and stored, ready to be thawed and fertilized at a later date.
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#5 Fertility Preservation Through Oocyte Cryopreservation:

Thanks to the new cryopreservation techniques developed in Italy and elsewhere, this novel reproductive technology is now allowing eggs of a healthy woman to be safely frozen and stored, ready to be thawed and fertilized at a later date.

Currently, oocyte cryopreservation is offered in more than 50% of assisted reproductive technology clinics in the United States. There have been 1,000 to 2,000 healthy births as a result of this novel egg-banking technology.
#6 Forced Exercise To Improve Motor Function in Patient's With Parkinson's:

Pedaling at 90 RPMs on a tandem bike to dramatically improve motor functioning of patients with Parkinson's disease.
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#6 Forced Exercise To Improve Motor Function in Patient's With Parkinson's:

Parkinson's disease (PD) is a debilitating brain disorder that affects more than 1 million Americans and has no cure. While current available medicines help ease the PD symptoms for a few hours, a novel exercise-based therapeutic strategy can now bring relief to patients for weeks. By conducting "forced exercise" (tandem riding in which patients are forced to pedal 80-90 RPM), patients' motor function was dramatically improved by 35% and this improvement lasted for 4 weeks after the training ended.

Used either alone or as adjunct to other therapies, forced exercise has opened up a promising avenue in PD treatment and management. Research continues at leading medical centers testing this non-pharmacological approach to PD. While awaiting definitive forced exercise study results, several groups now sell motorized at-home pedaling devices to mimic bicycle pedaling at high RPMs.
#7 Outpatient Diagnosis of Sleep-Related Breathing Disorders:

Self-contained, reliable, at-home sleep-monitoring devices for screening, diagnosing, and treatment assessment of sleep-related breathing disorders.
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#7 Outpatient Diagnosis of Sleep-Related Breathing Disorders:

Sleep-related breathing disorders have historically been assessed by means of an all-night sleep study in a hospital-based sleep disorder lab. With the increase of public awareness of sleep-related disorders, there are not enough sleep centers to meet the burgeoning demand for diagnosis. That is now changing with the introduction of the patient-friendly self-contained sleep-monitoring devices that allow for the sleep testing to be performed anytime in a patient's home. Data collected through testing can be accessed by clinical professionals for further analysis.

Recent studies have shown that home portable monitor testing is as effective as traditional sleep lab testing in the screening and diagnosis of sleep-related breathing disorders. With improved patient access to care and reduced costs, home testing continues to replace inpatient testing as a viable alternative.
#8 Oral Thrombopoeitin (TPO) Receptor Agonist That Stimulates Platelet Production:

A recently approved drug that stimulates production of cells in bone marrow that form platelet cells in the blood.
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#8 Oral Thrombopoeitin (TPO) Receptor Agonist That Stimulates Platelet Production:

An estimated 50,000 to 100,000 people in the United States are diagnosed with chronic immune thrombocytopenic purpura (ITP). Patients with ITP have low blood platelet count that may produce bruising or excessive bleeding. While most cases of ITP can be controlled, the response to medication is often disappointing and associated with risk. A recently approved oral thrombopoietin receptor agonist has shown high effectiveness in the treatment of ITP by stimulating production of cells in bone marrow that form platelet cells in the blood. Patients taking this new drug were 10 times more likely to reach the target platelet counts as the control group.

Further studies are ongoing to evaluate the safety and efficacy of the drug not only as a long-term treatment for ITP, but as a possible treatment for patients with or patients receiving chemotherapy for leukemia. The drug received full FDA approval in 2008 for treatment of ITP. A Phase III clinical trial for the use of the drug in hepatitis-C-related thrombocytopenia has been completed and results are pending.
#9 Devices for Occluding Left Atrial Appendage to Reduce Stroke Risk:

Device alternatives to long-term warfarin use that can prevent clots from developing in patients with atrial fibrillation.
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#9 Devices for Occluding Left Atrial Appendage to Reduce Stroke Risk:

Compared to people with normal heart rhythm, patients with atrial fibrillation (AF) have a five-fold increased risk of suffering a clot-related stroke and thus have to take anticoagulant medications, such as warfarin, to manage their AF-related stroke risk. However, warfarin is a problematic medication to use and the drug dosage needs to be monitored regularly. By implanting a left atrial appendage occlusion device, which is specially designed to prevent the formation of blood clot, patients may now discontinue warfarin use.

In 2010, the FDA recommended another study to provide more safety and effectiveness data before the device can be approved.
#10 Whole-Slide Imaging for Management of Digital Data In Pathology:

A technology for creating digital pathology slides with excellent image quality that can be viewed, stored, streamed over the Internet, and analyzed on a computer.
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#10 Whole-Slide Imaging for Management of Digital Data In Pathology:

Whole-slide imaging is a new technology that converts conventional glass slides into digital pathology slides with excellent image quality that can be viewed, managed, stored and streamed over the Internet, and analyzed on a computer. With this technology, pathologists can now scan a slide within seconds and share it immediately and conveniently with peers anywhere in the world.

This technology offers tremendous promise for improving patient care by delivering faster diagnoses, reducing patient morbidity and mortality, and lowering overall medical costs. In addition to supporting primary diagnosis, it also provides valuable information to personalized medicine.

The U.S. Patent and Trademark Office reissued the patent to a digital pathology company for the techniques involved in the processing and displaying of digital slide images stored on a server.

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