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Ramon Quesada, MD, FACP,FACC, FSCAI

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Presentation on theme: "Ramon Quesada, MD, FACP,FACC, FSCAI"— Presentation transcript:

1 Ramon Quesada, MD, FACP,FACC, FSCAI
Design Update of NMT for PFO Closure 2010 Ramon Quesada, MD, FACP,FACC, FSCAI Medical Director, Interventional Cardiology Baptist Cardiac & Vascular Institute Miami, Florida

2 Ramon Quesada, MD DISCLOSURES
I have no real or apparent conflicts of interest to report.

3 Disclosure Statement of Financial Interest
Within the past 12 months, I or my spouse/partner have had a financial interest/arrangement or affiliation with the organization(s) listed below. Affiliation/Financial Relationship Company Grant/Research Support None Consulting Fees/Honoraria Abbott, Cordis, St. Jude, W.L. Gore, NMT Medical, Terumo & Boston Scientific Corporation Major Stock Shareholder/Equity None Royalty Income None Ownership/Founder None Intellectual Property Rights None Other Financial Benefit None

4 The Clinical Dilemma PFOs exist in about 25% of the population
There are two major indications for PFO closure Cryptogenic Stroke Migraine Other conditions potentially linked to PFO Dementia Alzheimer’s Decompression illness in divers Perioperative Hypoxemia Pulmonary Embolism Chronic Obstructive Pulmonary Disorder (COPD) Obstructive Sleep Apnea Transient Global Ischemia 4

5 The NMT Devices CardioSEAL® STARFlex® BioSTAR® BioTREK™ Permanent
Partially or Completely Bioabsorbable BioSTAR® BioTREK®

6 CardioSEAL® Long history of use (>22,000 implanted)
FDA approved for PFO (via HDE) until 2006; current FDA approval for high risk VSD’s MP35n frame for excellent corrosion resistance & polyester fabric for proven endothelialization 98% closure rate documented in PFOs1; 80% in ASDs2 Catheter Cardiovasc Interv 2006; 68(1): J Am Coll Cardiol 2006; 48:538–44.

7 STARFlex® CE Mark since 1998 (>6,000 implanted)
IDE studies in US for ASD and PFO (CLOSURE I) & OUS Migraine Trial (MIST) CardioSEAL® frame with addition of a PFO-compatible nitinol centering mechanism improves conformability in difficult anatomy 94% closure rate documented in PFOs1; 93% in ASDs2 Circulation 2008; 117: J Am Coll Cardiol 2006; 48:538–44.

8 Anatomical Issues: Device Solutions

9 Anatomical Challenges
Long tunnel > 16 mm Large septal aneurysm with eccentric tunnel Fenestrated atrial septum

10 Anatomical Challenges
Long tunnel > 16 mm Large septal aneurysm with eccentric tunnel Fenestrated atrial septum

11 29 mm PFO channel

12 Measurement 29 mm PFO channel
+ +

13 Transeptal Puncture –29 mm PFO channel

14 Closure with 33mm CardioSEAL®

15 Important Tip: For a long channel (> 16 mm) with or for a large associated ASA consider trans-septal puncture to avoid “confining” of the right atrial component of the device within the channel

16 Confined right atrial component within channel
Case 2a Confined right atrial component within channel

17 Case 2a Post release right atrial component confined  snared to properly reposition the device

18 Anatomical Challenges
Long tunnel > 16 mm Large septal aneurysm with eccentric tunnel Fenestrated atrial septum

19 Case 2 Large ASA Cut to section where > appears--done

20 Catheter through Fenestration
Case 2 Catheter through Fenestration Trnaspeptal with circle make it into short film

21 Catheter through Fenestration
Case 2 Catheter through Fenestration Trnaspeptal with circle make it into short film

22 Closure with 33mm CardioSeal® with Stabilization of ASA
Case 2 Closure with 33mm CardioSeal® with Stabilization of ASA Launez transeptal

23 PFO Repair via Transseptal Puncture
28/255 (10.9%) PFO Procedures used transseptal puncture technique Overall mean channel length 14.4 mm PFO/ASA n= 13 Mean Channel 14.7 PFO n= 15 Mean Channel 14.4 Results : 100% success with no shunts and no complications

24 New Technology BioSTAR® Bioabsorbable Tissue-engineered
Collagen Matrix BioTREK™ Bioabsorbable Biosynthetic Polymer

25 Why bioabsorbable? less risk of long term complications
potential to regenerate functional tissue allow future interventions improved MRI imaging avoidance of chronic foreign body reaction1 patient preference 1. Heart 2006;93(4):444-9

26 BioSTAR® First use of bioabsorbable material for structural heart repair Novel Features Real Clinical benefits1 Rapid endothelialization -High early closure rates -Reduced risk of thrombosis Regeneration of native-like septum -Improved potential for LA access later in life 1. Circulation 2006; 114:1962-7

27 BioSTAR® Implant Design
Tissue-engineered collagen matrix derived from the submucosal layer of the porcine small intestine (ICL) (Organogenesis Inc., Canton, MA) close hole acutely function as a “bioremodeling” template for the ingrowth of host cells Proven STARFlex® framework Heparin coating CE Mark since 2007 (>2,000 implanted)

28 BioSTAR® Septal Repair Implant

29 BioSTAR® Pre-clinical Findings
Compared to STARFlex® (control), the BioSTAR® showed an accelerated healing response First signs of a single-layer neo-endothelium were observed already after 7 days in vivo Heparin coating of the BioSTAR® surface reduced surface thrombogenicity The ICL collagen matrix exhibited a surprisingly low immune response J Am Coll Cardiol 2006; 48:161-9

30 BioSTAR® Remodeling Absorption was approximately 90% complete at 2 years with no fibrous capsule formation 30 days 2 years J Am Coll Cardiol 2006; 48:161-9

31 Comparative Healing Response
30d 180d STARFlex® BioSTAR® At both time periods, BioSTAR® demonstrated more extensive tissue encapsulation and better sealing to the atrial wall as compared to STARFlex® Photos courtesy of Dr. Christian Jux, University of Goettingen/Germany and Dr. Peter Wohlsein, Institute of Pathology, School of Veterinary Medicine Hannover/Germany

32 Comparative Thrombogenicity
STARFlex® ICL no heparin BioSTAR® After 7 days, the heparin coated BioSTAR® showed lower levels of plasma protein deposition than STARFlex® and an uncoated BioSTAR® Photos courtesy of Dr. Christian Jux, University of Goettingen/Germany and Dr. Peter Wohlsein, Institute of Pathology, School of Veterinary Medicine Hannover/Germany

33 BioSTAR® Evaluation Study (BEST) Clinical Trial
Follow-up ASA 75mg OD; Clopidogrel 75mg OD for 3 months Contrast TTE at baseline, 30 days and 6 months TEE at implant and 30 days Studies reviewed by echo core lab Inflammatory markers at baseline, 30 days and 6 months Slide courtesy M Mullen, Royal Brompton, London, UK

34 BEST Results N % N % 57/58 patients successfully had a BioSTAR implant
Closure at 30 days 48/52 92 Closure at 6 months 54/56 96 Safety – No major safety issues: N % Atrial arrhythmia % resolved Urticuria % resolved RA echogenic mass % resolved Slide courtesy M Mullen, Royal Brompton, London, UK

35 BioSTAR® Evaluation Study (BEST) Immunological Markers
HS-CRP ESR mg/dl mm/hr 32 136 31 48 26 14 14 12 12 10 10 8 8 6 6 4 4 2 2 BL 4 12 26 BL 4 12 26 weeks weeks Slide courtesy M Mullen, Royal Brompton, London, UK

36 BioSTAR® Advantages High closure rates in wide range of PFO defect morphologies 30d; 6 mos. (Mullen 2006) No PFO patients excluded due to anatomy Long tunnel, ASA, thick septum secundum 90-95% bioabsorbable Regenerates native-like septum (Jux 2006) Potential for future LA access Low thrombogenicity Heparin coated Rapid endothelialization (Jux 2006) Simple to use With RT delivery system: Free implant/delivery system interface

37 BioTREK™ Bioabsorbable Septal Repair
100% absorption over time Novel bioabsorbable polymer (P4HB) absorbs as a non-inflammatory natural metabolite Easily repositionable and retrievable Radiopaque and echogenic Currently in pre-clinical studies P4HB stands for poly-4-hydroxybutyrate It breaks down to form 4-hydroxybutyric acid 6 months Explant photo courtesy of Aaron V. Kaplan, MD and Ebo D. de Muinck, M.D. Ph.D., Dartmouth Medical School (USA)

38 BioTREK™: Polymer (P4HB)
Novel biomaterial received 1st FDA clearance 2007 (sutures/meshes) Biologically produced isolated from bacteria modified by recombinant DNA technology1 no residual metal catalysts More flexible & less inflammatory than currently available bioabsorbables P4HB in recombinant bacteria Production by biological fermentation has value because such materials do not contain residual metal catalysts such as those used in chemical synthesis (which can cause inflammation) 1. Biochemical Engineering Journal 2003;16:97-105 Photo courtesy Tepha, Inc.

39 BioTREK™ Key Design Goals
complete closure within 30d no permanent foreign material easily retrievable & repositionable no change to current procedure radiopaque & echogenic conformable and atraumatic low thrombogenicity intuitive delivery effective in most shapes/sizes of PFO’s You should be aware that BioTREK, in its current configuration, is a PFO specific design – smaller LA side than RA which helps with achieving good apposition in a double disc design (unlike an umbrella where the legs can be “crossed” before deployment). We do have ASD specific concepts as well.

40 BioTREK™ Implant PFO Specific Design: LA side < RA side Frame
You should be aware that BioTREK, in its current configuration, is a PFO specific design – smaller LA side than RA which helps with achieving good apposition in a double disc design (unlike an umbrella where the legs can be “crossed” before deployment). We do have ASD specific concepts as well. Scaffold

41 Preclinical: ICE Imaging
ICE image at implant showing good aposition to heart wall in pig model. FYI - typically use sheep for all our healing studies but happened to be doing an acute study here.

42 Preclinical: Fluoroscopic Imaging
Fluoro image at implant in pig model. FYI - typically use sheep for all our healing studies but happened to be doing an acute study here.

43 Gross Images: 1 Month RA LA
Pre-clinical testing of BioTREK was conducted using the sheep model (female sheep 5-6 months old) Defect creation was done using Brockenbrough technique and a non-compliant balloon {12mm 12 atm (3 x 30 sec)} Device implantation occurred 2 weeks later RA LA

44 Gross Images: 6 Months RA LA
Here we have 6 month gross and histology images from the animal model. As you can see, the device is well healed with granulation tissue, mainly fibrosis (fibroblasts and collagen). RA LA

45 Histology: 1 Month At 1 mo:
-well healed with granulation tissue, mainly fibrosis (fibroblasts and collagen) -apparent endothelial cell coverage on surface -a very low inflammatory response -although very little resorption of the material

46 Histology: 6 Months Strut Scaffold And at 6 mo:
-resorption continues as confirmed through MW loss -foreign body response is still low which is promising although longer term data is needed Note: minimal or no focal chronic inflammation seen at 6 months

47 Summary In preclinical studies, BioTREK™ has achieved:
No permanent foreign material Easily retrievable & repositionable No change to current procedure Radiopaque & echogenic Minimal chronic inflammation BioTREK™ has the potential to achieve effective closure without chronic inflammation or permanent implant Status: Current focus is continuing to optimize the design including improving ease of use, healing rate, and conformability Next step will be to conduct our pivotal animal study Timing is TBD ask Frank what he wants to say here - hopefully we will start pivotal animals sometime in 2010 and then a human clinical trial could start approximately mos. later

48 International Symposium on Endovascular Therapy
I S E T Save the Date January, 2011 Thank You


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