The Major Costs of Minor Miracles: Technology on the Horizon

1. The Major Costs of Minor Miracles:Technology on the Horizon Stacy M. Borans, MD Chief Medical Officer Advanced Medical Strategies

2. Learning ObjectivesFor Medical Devices • Understand their clinical indications • Know the mechanisms of action • Be able to anticipate their costs • Understand the cost-benefit ratios • Be aware of new(er) technologieson the horizon

3. In the News… Girl doing well after transplant Before finding the donor organ,a Berlin pump kept her alive. The Food and Drug Administration gave emergency approval for the hospital to bring a pump and backup unit from Germany.

4. Introduction • Health care spending consistently increases ata rate of approximately 7.5% • Health care premiums have also increased at the same rate • Fifteen medical conditions account for the majority of the growth in healthcare spending • 20-40% of that growth can be attributedto new technology developments

5. Obesity • Obesity: Body mass index (BMI)between 30 and 39 • Morbid obesity: BMI greater than 40 • Increased risk of hypertension, diabetes mellitus, coronary artery disease, breast and colon cancer and gallbladder disease • Americans classified as such: 60 million

6. Obesity:Implantable Gastric Stimulator • Intended for patients with a BMI between 30 and 55 who have failed conventional weight loss treatments • Pacemaker-like device • Device induces the feeling of fullness (satiety) • Mechanism of action is not well understood

7. Obesity:Implantable Gastric Stimulator

8. Obesity:Implantable Gastric Stimulator • Implanted under the skin of the abdomen • Leads and electrodes are inserted into the stomach wall and fastened to the muscle • Activated approximately 30 days after implantation • Minimally invasive and can be performed in the outpatient setting

9. Obesity:Implantable Gastric Stimulator • Early Results: 30% of baseline weight lost • Weight loss maintained for 3 years • Estimated cost of $10,000•includes stimulator and leads • Additional Costs for implantation • Long term benefits are the reduction of the comorbid conditions

10. Degenerative Disc Disease • Extremely Common Cause ofLow Back Pain (LBP) • Loss of water content in discs causestwo vertebrae to move closer together • Conservative treatment is first-line • Severe cases require surgery: spinal fusion • Rods • Screws • Back Cages

11. Degenerative Disc Disease:Charité Artificial Disc • Patients with only one diseased disc • between L4 and L5 or • between L5 and S1 • Fail six months of conservative treatment • Cannot be used in patients with DDD at more than one level • Patients cannot have osteopenia or osteoporosis

12. Degenerative Disc Disease:Charité Artificial Disc

13. Degenerative Disc Disease:Charité Artificial Disc • Diseased disc removed and replaced with artificial disc • Restore proper disc height between the vertebrae above and below the disc • Maintain motion in the area of the spine where the disc is implanted • Re-establish proper spinal alignment/ curvature of the lumbar spine

14. Degenerative Disc Disease:Charité Artificial Disc • Lack of long-term follow up studies • Invoice Price for the device is $11,500 • Procedure costs for a single disc are$30,000 to $45,000 • Long Term Benefits over spinal fusion were primarily greater flexibility

15. Coronary Artery Disease • Leading cause of death in bothwomen and men • Earlier detection allows forbetter outcomes • Evaluate risk factors and recommend appropriate testing • Typically requires invasive methods to get most accurate clinical picture

16. Coronary Artery Disease:64 Slice CT scanner • FDA Approved in 2004 • Cost to the facility: $1.8 million/scanner • Ability to non-invasively image the heart in extreme detail • Ultrafast • May be able to use in ER to assess and discharge

17. Coronary Artery Disease:64 Slice CT scanner

18. Coronary Artery Disease:64 Slice CT scanner • Patients will still require cardiac cath • Expense: $1000-$2000 per scan • May have other applications • Inappropriate use risks exposure to substantial radiation • Currently still in clinical trials,but anticipate widespread use

19. Congestive Heart Failure • Five million people in the US suffer from heart failure. • End stage CHF has very limited treatment options • Only 2,500 cardiac transplants completed per year due to organ availability • Left ventricular assist device used as bridge to transplant

20. Congestive Heart Failure:AbioCor Implantable Replacement Heart • Strict Patient Criteria • End stage heart failure • Life-expectancy of less than 30 days • Not heart transplant candidates • Have no other viable treatment options • Patients are not candidates for LVAD or will not benefit from LVAD insertion

21. Congestive Heart Failure:AbioCor Implantable Replacement Heart • Multiple Components of device • Internal Components: artificial ventricles, hydraulic pumping system, rechargeable battery and electronics package • External Components: external console or battery packs

22. Congestive Heart Failure:AbioCor Implantable Replacement Heart

23. Congestive Heart Failure:AbioCor Implantable Replacement Heart • Inpatient Implantation • Patients placed on cardiopulmonary bypass • The diseased heart is replaced andthe Abiocor is connected to the native blood vessels • Implantation of the transcutaneous energy transfer coil, controller, and battery pack.

24. Congestive Heart Failure:AbioCor Implantable Replacement Heart • Currently in trials at selected centers • No long term studies available to assess either safety or efficacy of the device • FDA Advisory Panel rejected application to widen use in 2005 • Cost estimates are $200,000-$250,000 for the total implantation

25. Cerebrovascular Disease • Strokes have an annual incidence of 700,000 • 75% of strokes are due to ischemic infarcts • 80% of ischemic infarcts are due to large vessel occlusion by atherosclerosis • Time to treatment is critical in preventing significant disability for affected patients

26. Cerebrovascular Disease:MERCI Retrieval System • FDA Approved in 2004 • Indicated for removal of blood clots from patients experiencing an ischemic stroke • Late Onset Presenters • Also used to remove foreign bodies inthe peripheral, coronary, andneuro vasculature

27. Cerebrovascular Disease:MERCI Retrieval System • System consists of Merci Retriever, microcatheter and balloon guide catheter • Retriever is designed to engage and capture the occlusive thrombus (clot) • Microcatheter is designed for placementof fluids and/or other devices or agents into vessels • Balloon provides temporary vascular occlusion during the procedure

28. Cerebrovascular Disease:MERCI Retrieval System

29. Cerebrovascular Disease:MERCI Retrieval System • Clot location confirmed by angiography • Balloon guide catheter is inserted intothe femoral artery and guided via x-rayto the carotid artery. • Retriever ensnares the clot, balloon guide catheter is temporarily inflated and the clot is withdrawn • Main goal is to reopen the artery before there is permanent neurologic damage.

30. Cerebrovascular Disease:MERCI Retrieval System • Clinical trial outcomes were good inselect patients • National Institutes of Health Stroke Scale score (NIHSS) greater than or equal to 10 • Treatment performed within 8 hours from symptoms’ onset • Occlusion of a major cerebral artery onthe angiogram • Contraindication to intravenous TPA (clot buster)

31. Cerebrovascular Disease:MERCI Retrieval System • Further studies in larger patient populations are needed • No reports of device related complications • Personnel training is needed • Estimated cost of the device is $9,000 • Other devices being evaluated forthe treatment of stroke

32. Prostate Cancer • Affects 1:6 men • Predominantly a disease of older men • African American men are 61% more likely to develop prostate cancer • 2.5 times more likely to die of the disease • Family history contributes to risk • Early Stage disease can be cured

33. Prostate Cancer:Robotic Prostatectomy • Minimally invasive surgery • Performed from a computerized workstation • Robotic arms perform the necessary movements including: • Hold and position an endoscope • Grasp, cut, dissect and cauterize • Suture tissue

34. Prostate Cancer:Robotic Prostatectomy

35. Prostate Cancer:Robotic Prostatectomy • Computer-enhanced system provide: • 3-D view of the surgical field, including depth of field, magnification and high resolution • Instruments that are designed to mimic the movement of the human hands, wrists and fingers • Master controls that allow the surgeon to manipulate the instruments • Magnifies the surgical field up to 15 times • Shorter hospital stay and less postoperative pain

36. Questions/Comments Thank you for attending!