AV Access Technology and Innovation DEVICES CHANGING HOW WE THINK ABOUT VASCULAR ACCESS

Transcription

1 AV Access Technology and Innovation DEVICES CHANGING HOW WE THINK ABOUT VASCULAR ACCESS

2 Vascular Access New Technology What problem are you trying to solve for? Most common problem is inadequate outflow Central stenosis Limited venous outflow real estate 2 nd most common problem is inadequate conduit Severe sclerosis of veins Rapid intimal hyperplasia Aneurysmal degeneration 3 rd most common problem is inadequate inflow Difficulty with the arterial anastomosis Which of the new technology products will be successful?

3 World Renown Vascular Surgeon Inflow Optiflow Outflow HeRO Hybrid Graft Conduit Acuseal, PROPATEN Tissue engineered grafts

4 HeRO - Outflow Solution Achieved Success in the Market

5 HeRO Catheter reduction Strategy Fewer Infections: 69% reduced infection rate compared with catheters1 Superior Dialysis Adequacy: 1.7 Kt/V, a 16% to 32% improvement compared with catheters High Patency Rates: Up to 87% cumulative patency at 2 years Cost Savings: A 23% average savings per year compared with catheters Salvaging a failing fistula due to central venous stenosis Salvaging a failing AV graft due to central venous stenosis Converting a catheter-dependent patient

6 VWING Conduit solution Obviates problems with native conduits (deep, limited cannulation space) Advances existing button hole concept Proven benefit Part of a catheter reduction strategy

7 GORE Hybrid Vascular Graft Provides a conduit and a venous anastomotic solution Very effective at navigating the hostile axilla

8 Hybrid Graft would be better than this!

9 GORE Hybrid Vascular Graft Conduit Solution + Outflow Solution Satisfies a niche when the venous territory is compromised

10 INTERGRAFT InterGraft System developed for minimally invasive placement of AV graft Sutureless anastomoses to vein, artery and graft Optimized flow dynamics

11 INTERGRAFT Pivotal, prospective, multicenter, non-randomized, single-arm Adaptive design with interim (mid-point) analysis Main study 104 subjects (up to197) roll-in phase -30 subjects VIG sub-study -25 subjects Up to 252 total subjects Currently of 2/2016 Enrolled 10 patients as

12 INTERGRAFT

13 INTERGRAFT

14 Optiflow Arterial anastamotic solution J Vasc Surg Apr;61(4): Results: Unassisted maturation rates (n=41) Optiflow at 90 days was 68% Control group at 90 days was 76%,

15 everlinq endoavf System Arterial Anastomotic Solution

16 everlinq The Novel Endovascular Access Trial (NEAT) NEAT primary endpoint Prospective, multicenter clinical study evaluating the everlinq endoavf System Data demonstrated that 91 percent of 60 study patients had a usable and unobstructed fistula within 3 months EndoAVF procedure was highly successful (98 percent) in creating an endoavf Study follow-up is ongoing out to 12 months at six investigational sites in Canada and Australia.

17 Ellipsys Vascular Access System Arterial Anastomosis Solution Creates fistula between artery and vein by welding and cutting an elliptical anastomosis. Procedure is performed with ultrasound guidance Used to create cephalic, basilic or median vein (reversed flow) fistulas Clinical trials Device has high technical and clinical success when deployed (100% technical and 82% clinical success in recent out of US trial) Proximal radial artery and perforating or radial vein is the site being used for clinical trials. End point is target vein (site for dialysis) Diameter > 4 and Flow > 500 ml or dialysis at prescribed rate. US Multi-center trial of 110 patients is on going at 5 sites.

18 Perforating Vein Anastamosis Multiple outflow channels Possible increased risk of venous congestion and steal syndrome Multiple veins for cannulation Cannulation sites may be uncertain

19 Humacyte Conduit Solution Favorable characteristics to eptfe More durable Bio-compatible

20 BAM Histology Fragmented Lamina Propria Increased Fibrosis BAM 15 months Nonareterialized control vein

21 Conclusion: The success of the new technologies depends on their ability to: Overcome central vein pathology Overcome conduit pathology Overcome anastomotic challenges Success in the market place will be driven by reimbursement as new technologies are brought to the market at a premium