TOPAZ TM What you should know

Transcription

1 TOPAZ TM What you should know Not for distribution in the United States.

2 Need to know 2 Tendon: is a tough band of fibrous connective tissue that connects muscle to bone and is capable of withstanding tension Ligament: is a tough band of fibrous connective tissue that connects bone to bone and is capable of withstanding tension Fascia: is a tough band of fibrous connective tissue that connects muscle to muscle and is capable of withstanding tension

3 Tendons 3 Structure: Normal healthy tendons are mostly composed of parallel arrays of collagen fibers closely packed together. The collagen provides great tensile strength. Function: Tendons are a mechanism by which muscles connect to bone, functioning simply py to transmit forces Pathologies: Different types of Tendinopathies or tendon injuries due to overuse, that exist and result in inflammation, degeneration, or weakening of the tendons, which may lead to ruptures (due to age, body weight, excessive use etc.)

4 Tendinitis 4 What is Tendinitis: Inflammation of a tendon Acute injury or overuse accompanied by inflammation Diagnosis: Swelling in the region of inflammation Pain or stiffness to the local area of the tendon, or a burning that surrounds the whole joint around the inflamed tendon Treatment: Use of non-steroidal anti-inflammatory drugs Rest Autologous blood injection Need to know: ACUTE reaction

5 Tendinosis 5 What is Tendinosis (aka chronic Tendinitis): Chronic degeneration without inflammation Caused by microtears in connective tissue around the tendon refers to non-inflammatory injury to the tendon at the cellular level degradation is caused by damage to collagen, cells, and the vascular components of the tendon Diagnosis: Swelling in the region of inflammation Increased water content and disorganized collagen matrix in tendon lesions may be detected t d by ultrasonography or magnetic resonance imaging i (MRI) Treatment: TOPAZ Shock-Wave-Therapy Platelet Rich Plasma (PRP): component of blood that contains aconcentrated amount of growth factors Need to know: Chronic disease TOPAZ!

6 Tendinosis 6 Diagnosis: MRI of normal plantar fascia MRI of abnormal thickened planar fascia

7 Tendinosis 7 Tendinosis... again, what is wrong? Lack of vascularity may compromise nutritional flow through the chronically ca injured tendon What are symptoms for the patient? Pain Less grip strength

8 Tendinosis 8

9 Tendinosis 9 Tendinosis... Need to break out the cycle!

10 Tendinosis 10 How to adress Tendinosis? stimulate an organized angiogenic healing response in an effort to reverse the avascular embodiments propagated by chronic injury. initiate angiogenesis in injured tendon tissue

11 Tendinosis 11 Why initiate angiogenesis? The goal is improved nutritional flow through the injured tendon and promotion of collagen remodeling. This will lead to decreased pain and improved function

12 Tendinosis 12 What is TOPAZ? Debridement for tendons : Bi-polar Radiofrequency based Microtenotomy or Coblation for tendons

13 TOPAZ F&A Update: The TOPAZ Difference 13 Quick, simple, minimally invasive procedure Same Coblation technology and equipment used in over 2 million procedures Designed to specifically address the problem: hypovascularity and collagen degeneration Stimulates the body s healing response No complications reported

14 TOPAZ 14 What can TOPAZ do? 1. Initiate Angiogenisis 2. Support Collagen Remodelling

15 TOPAZ: Angiogenisis 15 Angiogenisis...how does it work? Angiogenic response could be initiated in tendon tissue by triggering a controlled inflammatory process to initiate healing. Need to know: Tendinosis is a chronic disease with the lack of initiatong an inflammation process.

16 TOPAZ: Angiogenisis 16 Why do we want a controlled inflammatory process? Inflammation process increase presensece of basic fibroblastic growth factor (FGF) and vascular endothelial growth factor (VEGF) Need to know: these growth factors contribute to angiogenesis, important for effective tissue healing

17 TOPAZ: Angiogenisis 17 FGF and VEGF? fibroblastic growth factor (FGF) Family of growth factors involved in angiogenesis. g FGFs are key players in the processes of proliferation and differentiation of wide variety of cells and tissues. vascular endothelial growth factor (VEGF) Platelet-derived growth factor. They are important for the growth of blood vessels from pre existing vasculature.

18 TOPAZ: Angiogenisis 18 Is there any external background science from other areas? Studies in cardiology have demonstrated distinct clinical benefits for using a surgical micropuncture technique to promoteangiogenesis for repair of the ischemic heart. Transmyocardial revascularization (TMR) has been reported to significantly reduce incidence and severity of angina and increase tolerance to exercise; these observations occurred simultaneously with evidence of enhanced vascularity.

19 TOPAZ: Collagen remodeling 19 Collagen remodeling... what s that? Tendinosis comes along with loose collagen bundles. The goal is to receive organized and tight collagen bundles.

20 TOPAZ: Collagen remodeling 20 Why do we want tight collagen bundles? Tight collagen bundles are arranged to a definite pattern resulting in: Less flexibility Greater resistence to stress Predominance of collagen fibres

21 TOPAZ 21 In a nutshell what is the outcome of TOPAZ treatement? Improved nutritional flow (angiogenesis) Collagen remodelling (greater resistance to stress) What does it mean for the patient? Pain relief Grip strength

22 TOPAZ 22 What are suitable TOPAZ applications? RC tendon Epicondyle (lateral, medial) Patellar tendon (jumpers knee) Achilles tendon Plantar Fascia

23 TOPAZ 23 Most of the papers p talk about Microtenotomy... what is that? (Micro-)Tenotomy is the cutting of a tendon. This and related procedures are also called tendon release During a tenotomy, the tendon is cut entirely or partway through, allowing the muscle to be stretched. Tenotomy may be performed through h the skin (percutaneous tenotomy) t or by surgically exposing the tendon (open tenotomy). The details of the operation differ for each tendon.

24 TOPAZ 24 What can TOPAZ do better than other treatmet options?

25 TOPAZ 25 TOPAZ Procedure

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28 TOPAZ 28 What are the key papers to support TOPAZ?

29 TOPAZ F&A Update: Clinical Evidence 29 Healing Response after Coblation Treatment Objective: To evaluate the safety and effectiveness of Coblation for the treatment of tendinopathy Study Design: Prospective, nonrandomized, single-center clinical study (n = 20) Patients with intractable symptoms of elbow (15), patellar (2) and Achilles (3) tendinopathy Mean duration of symptoms: 3.5 years Average number of failed conservative treatments: 4.5 Study Results: Coblation microtenotomy significantly improved pain symptoms No complications or adverse events occurred, demonstrating the safety of treatment of tendinosis with Coblation Clinical improvement endured through 2 years in most patients with scores measuring between 90-92% good to excellent results according to VAS A larger prospective, multicenter controlled study to be conducted to confirm encouraging results* JP Tasto et al. Arthroscopy (December, Suppl 1);19(10): ) *JP Tasto et al. Arthroscopy. 2005;21(7):

30 TOPAZ F&A Update: Clinical Evidence 30 Summary of Results: Pain Reduction Ranged from 5-10, median score of 8 VAS 7-10 days post-op Ranged from , median score of 2 S Score M edian VA Baseline 7-10 Days 2-3 Weeks 4-6 Weeks 3 Months 6 Months 12 Months 24 Months Visual analog scale (VAS): 10 = intense pain; 0 = no pain

31 TOPAZ XL Technology Review: Study Review 31 SAD vs. brf for Treatment of Rotator Cuff Tendinopathy Objective: To measure pain reduction and functional improvements one year post-op in patients treated using brf compared to patients receiving conventional SAD Study Design: 60 patients - 30 traditional SAD/30 brf Presence of tendinosis was confirmed by MRI or ultrasound Study Result: Proved the acromiom does not have to be removed in order to treat tendinosis, debridement is just as effective Ettore Taverna, et al. Radiofrequency-Based Plasma Microtenotomy Compared to Arthroscopic Subacromial Decompression Yields Equivalent Outcomes for Rotator Cuff Tendinosis. Arthroscopy. October 2007.

32 TOPAZ XL Technology Review: Study Review 32 SAD vs. brf for Treatment of Rotator Cuff Tendinopathy Short-Term Significant ifi reduction of pain and improved function were observed in both treatment groups immediately post-op Long-Term Both treatment t t groups demonstrated t d almost identical recovery profiles through h the first year post-application brf is capable of achieving a similarly beneficial clinical result to SAD; calling into question the need to perform the more extensive intervention

33 TOPAZ F&A Update: Clinical Evidence 33 Radiofrequency Microtenotomy: A Promising Method for Treatment of Recalcitrant Lateral Epicondylitis Objective: To assess the RF microtenotomy procedure for treating epicondylitis by comparing it with the release and repair of the extensor tendon Study Design: Sample Size: 24 patients with positive diagnosis of tendinosis of the lateral epicondyle of the elbow. All patients had completed at least 1 year of conservative therapy. Procedural Methods: Patients were randomized into two treatment groups; 11 patients received the extensor tendon release repair and 13 patients were treated with microtenotomy using the TOPAZ MicroDebrider. Evaluation Methods: Evaluations were performed with the following three assessment measures preoperatively as well as 3, 6 and 12 weeks post-operatively. Visual Analog Scale (VAS) pain evaluation Mayo Elbow Performance Score (MEPS) functional improvement evaluation Grip Strength Khaled Meknas, Åshild Odden-Miland Miland, James B. Mercer, Miguel Castillejo and Oddmund Johansen Am. J. Sports Med. 2008; 36; 1960 originally published online Jun 16, 2008

34 TOPAZ F&A Update: Clinical Evidence 34 Radiofrequency Microtenotomy: A Promising Method for Treatment of Recalcitrant Lateral Epicondylitis Objective: VAS: Pain in the microtenotomy-treated group but not in release method patients decreased significantly at three weeks. The microtenotomy-treated t t t group experienced an earlier improvement in VAS pain scores, early improvement was not found in release method patients. The rapid decrease in pain experienced by the microtenotomy-treated group may indicate that local neural ablation was induced. It is also obvious that microtenotomy induces less damage to surrounding tissues during the operation, likely decreasing the incidence of pain often caused by surgical intervention. Grip Strength: At 12 weeks, grip strength had improved significantly in the microtenotomytreated group but not in the release group. The microtenotomy-treated treated group experienced an increased in grip strength, the release method group did not. MEPS: Improvement was noticeably significant in both groups at 12 weeks. Khaled Meknas, Åshild Odden-Miland, James B. Mercer, Miguel Castillejo and Oddmund Johansen Am. J. Sports Med. 2008; 36; 1960 originally published online Jun 16, 2008

35 Prepared by: ArthroCare International Not for distribution in the United States ArthroCare Corporation. All trademarks, service marks and logos listed herein are registered and unregistered trademarks of ArthroCare Corporation, its affiliates or subsidiaries or a third party who has licensed its trademarks to ArthroCare ArthroCare Corporation. All trademarks, service marks and logos listed herein are registered and unregistered trademarks of ArthroCare Corporation, its affiliates or subsidiaries or a third party who has licensed its trademarks to ArthroCare.