THE NEXT GENERATION IN DVT TREATMENT

PORTABLE, LIGHTWEIGHT MECHANICAL COMPRESSION

FlowMedic/Homefit + Bridge Medical Orthopedics

FlowMedic/Homefit Established in 2003 Developed several products based on its core technology: -Venous flow enhancement for DVT prevention (Aviafit/Homefit). FDA approved. -DVT prevention and in-hospital use.

Understanding DVT
Deep Vein Thrombosis (DVT) is a blood clot formed in the deep veins, mostly in the lower extremities. In its fatal form, the clot travels through the venous systems to the lungs and causes a Pulmonary Emboli (PE). More than 200,000 Americans die each year from DVT complications. Surgical patients are at high risk for DVT and often receive preventive treatment. Such preventive treatment usually includes anticoagulant drugs and lower extremities mechanical compression. Anticoagulant drugs interfere with the body's clotting mechanism and aid in dissolving clots. Compression devices aid in preventing clot formation by imitating the action of the calf muscles and increasing venous flow velocity. Both modes of DVT prevention have been proven effective. Anticoagulant drugs are associated with side-effects that include excessive bleeding. Compression devices suffer from low patient compliance. Compression therapy would be the ideal if compliance can be increased.

Bridge Medical Orthopedics Exclusive U.S. distributor 855.388.7867 or 913.213.5637, office 877.504.1409, fax info@bridgemedortho.com www.bridgemedortho.com

ACCP & AAOS Support

ACCP: In patients undergoing THA or TKA, the expert panel recommends use of one of the following for a minimum of 10 to 14 days rather than no antithrombotic prophylaxis: low-molecular-weight heparin (LMWH), fondaparinux, apixaban, dabigatran, rivaroxaban, low-dose unfractionated heparin (LDUH), adjusted-dose vitamin K antagonist (VKA), aspirin (all Grade 1B), or an intermittent pneumatic compression device (IPCD) (Grade 1C)1. AAOS: The work group suggests the use of pharmacologic agents and/or mechanical compression devices for the prevention of venous thromboembolism in patients undergoing elective hip or knee arthroplasty, and who are not at elevated risk beyond that of the surgery itself for venous thromboembolism or bleeding (Grade of Recommendation: Moderate). Current evidence is unclear about which prophylactic strategy (or strategies) is/are optimal or suboptimal. 2
1 Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Falck-Ytter Y, Francis CW, Johanson NA, Curley C, Dahl OE, Schulman S, Ortel TL, Pauker SG, Colwell CW Jr. Prevention of VTE in orthopedic surgery patients: antithrombotic therapy and prevention of thrombosis, 9th ed: American College of Chest Physicians evidence-based clinical practice guidelines. Chest 2012 Feb;141(2 Suppl):e278S-325S.

Homefit Device Set

+2 homefit devices +2 sleeves +One carrying bag +User Manual + Instruction Card +4 AA batteries +Part Number: 100 934AB-ES +Each device has unique serial numbers for Medicare and billing purposes. +Homefit sets are packed in boxes of 12 sets +Part Number: 100 662VC- ES +Homefit DVT, model #100 934 AB-ES, isapproved by PDAC HCPCS E0676 Intermittent limb compression device (includes all accessories), not otherwise specified.

Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. American Academy of Orthopaedic Surgeons (AAOS). Preventing venous thromboembolic disease in patients undergoing elective hip and knee arthroplasty. Rosemont (IL): American Academy of Orthopaedic Surgeons (AAOS); 2011. 824 p.
2

Homefit Works
It is a lightweight, completely portable DVT prevention unit that applies mechanical compression to stimulate circulation of blood in the legs while creating a pleasant, massaging effect while in use. Can be worn on one or both legs, over or under clothing. Use for home, office or travel. Homefit prevents blood stagnation and reduces the risk of life-endangering blood clot formation. It provides the same hemodynamic benefit as larger conventional intermittent pneumatic compression devices. Its potential advantages for prophylaxis of thromboembolism and increased compliance in rehabilitation and homecare, and for use during long periods of immobility, are evident.

Homefit Physiological Effects

Improved circulation in arteries that may be stiff due to diabetes, atherosclerosis, or other circulatory problems without causing user discomfort and associated low compliance - a major drawback of Intermittment Pneumatic Compression (IPC) devices). Increased arterial-venous pressure difference (by enhancing venous return) through mechanical compression.

homefit DVT PREVENTION

Extends pain-free walking distances for improved quality of life.

Homefit Clinicial Trials Deep Vein Thrombosis (DVT) and Pulmonary are Portable, Lightweight, Effective. Emboli (PE) the leading cause of in-hospital

The next generation in portable, mechanical compression

Significantly increases quality of patient care for DVT prevention post-op, where the risk continues once a patient has been sent home.

FEATURES:

death. Lead to more thanP 200,000 in the Increases atient deaths Compliance. United States every year. Surgical patients are at Up to 40 hours of Continuous Operation. the highest risk of developing DVT. Most receive For Use A t-Home, Post-Operative. DVT prophylaxis during their hospitalization period in the form anticoagulant drugs or mechanical of Prevents Blood Stagnation & Reduces compression devices or both. Mechanical Risk of Life-Endangering Blood Clot compression devices are large and cumbersome. Result in low Formation. patient compliance leading to poor outcomes. Portable compression devices can compliance and hence improve clinical improve outcomes. Venous Indications DVT Prophylaxis

Homefit Clinical Trials

In several clinical trials a portable compression device has shown superior outcomes compared to stationary compression devices and to the leading anticoagulant drug. The Aviafit/Homefit is a miniaturized, portable compression device. Smaller than any other existing compression device, it has shown it is effective in increasing venous blood flow velocity; in preventing venous stasis; in providing the same hemodynamic benefits as larger conventional intermittent pneumatic compression devices; and in the overall bleeding risk profile favors the use of compression over subcutaneous heparin therapy. The goal of the Comparative Hemodynamic Study of Mechanical Compression Devices for Venous Thromboembolism Prophylaxis was to compare the Aviafit/Homefit device to an existing compression device. Flow velocity was measured at the Superficial Femoral Vein (SFV) with Doppler imaging. The study compared the acceleration of venous blood flow velocity for 20 subjects using two devices. Each subject underwent five consecutive measurements of peak venous flow velocity with each device and activation on a single calf using Doppler examination. The study results were the average peak venous flow velocity was 49.67 and 43.61 for Aviafit/ Homefit (Device 1) and KCE (Device 2), respectively. Repeated Measures Analyses of Variance (ANOVA) revealed no statistically significant difference among the devices (p >0.05). The study concluded the battery-operated, smaller portable compression devices demonstrate equal peak venous flow velocity when compared to the conventional SCD device. With improved compliance, this may result in improved clinical outcomes.
Reference: Comparative Hemodynamic Study of Mechanical Compression Devices for Venous Thromboembolism Prophylaxis. Wayne M. Goldstein MD, Ritesh R. Shah MD, Jill Branson RN, BSN, Shadi G. Khania, BA. University of Illinois at Chicago/Illinois Bone and Joint Institute/Advocate Lutheran General Hospital.

Results of the mechanical compression versus subcutaneous heparin therapy in postoperative and post-trauma patients study suggests that the overall bleeding risk profile favors the use of compression over heparin with benefits in term of venous thromboembolic disease prophylaxis being similar between groups.
Reference: Eppsteiner, Robert W., Shin, Jennifer J., Johnson, Jonas, and van Dam, Rob M. Mechanical Compression versus Subcutaneous Heparin Therapy in Postoperative and Post-trauma Patients: A Systematic Review and Meta-Analysis. World J Surg (2010). 34:10-19. DOI 10.1007/s00268-009-0284-z

In the study titled A novel intermittent mechanical compression device for stasis prevention in the lower limbs during limited mobility situations, found the lightweight, battery-operated and user-friendly Aviafit/ Homefit can provide the same hemodynamic benefits as larger conventional intermittent pneumatic compression devices. It has potential advantages for prophylaxis of thromboembolism and increased compliance in rehabilitation and homecare, and for use during long periods of immobility such as during flights are evident.
Reference: Galili, Offer, Mannheim, Dalit, Rapaport, Sigalit, Karmeli, Ron. A novel intermittent mechanical compression device for stasis prevention in the lower limbs during limited mobility situations. Department of Vascular Surgery, Carmel Medical Center. Haifa, 34362 Israel. Thrombosis Research. (2007). 121, 37-41. Additional clinical trials and information can be found at www. http://www.bridgemedortho.com/homefit/