Commercial presentation 3D custom-made implants 20/04/2016 1 For - PowerPoint PPT Presentation

Commercial presentation 3D custom-made implants 20/04/2016 1 For internal use only

AnatomikModeling is the result of 10 years of research and development with T oulouse University Hospital, to develop a particularly innovative computer-aided design (CAD) technology for 3D custom-made implants, as well as a mini-invasive surgical method to implant them. Sebbin has been manufacturing and marketing implants, particularly breast implants, for plastic and reconstructive surgery all over the world for 30 years. AnatomikModeling and Sebbin partnered to develop an innovative product and market this new solution in Europe. Design through computer-aided designing (CAD) and manufacturing of silicone custom-made implants. These implants are perfectly fitting each patient’s anatomy to compensate for a congenital deformity or trauma Medical care of pathologies such as Pectus Excavatum (funnel chest), Poland syndrome (complete or partial absence of the pectoralis muscle) or other muscle deficiency (calf atrophy). 20/04/2016 2

PATHOLOGIES Pectus Excavatum  Malformation of the thorax characterised by a median or lateral depression of the sternum.  Pectus Excavatum occurs in 1 to 2% of the population.This is the most common congenital thoracic deformity with an incidence of 1 in 300 births. 1 woman for 5 men.  Only 15% of those with a Pectus Excavatum are being operated on.  Very rare functional impact, but strong psychological one.  Pectus often affects the breast shape in women : high and low convergence, and asymmetry 3 20/04/2016

PATHOLOGIES Poland Syndrome  Complete or partial absence of the pectoral muscle. Poland cases are thus very different from one to another.  1 case out of 30000 births. Can be associated with a malformation of the ipsilateral hand  The defect often takes the form of a depression under the clavicle and in women by a breast asymmetry.  Can be associated with a deformation of the rib cage 20/04/2016 4

PATHOLOGIES Muscle deficiency  Congenital or acquired muscular hypotrophy or agenesis : calf atrophy in particular  Talipes equinovarus, sequelae of polyomyelitis, degenerative diseases, traumatic and/or surgical sequelae 20/04/2016 5

TECHNOLOGY Design  Creation of a 3D virtual copy of each patient’s body from hospital patient CT scan with millimetric precision (1 to 1,2)  3D reconstruction requiring complex mathematical algorithms for medical imaging processing.  Segmentation of each tissue : bones, muscles, skin, cartilages  Design of the virtual implant on each patient’s 3D digital body : based on 2 planes (anterior anatomical plane and posterior surgical plane.  Control and optimisation of the result with the direct participation of the surgeon in charge. 20/04/2016 6

TECHNOLOGY Manufacturing  Manufacturing of an Elastomer Prototype to get a perfect silicone anatomical copy, which will be the future implant.  Manufacturing of a mould from the prototype.  Casting of the medical polymerised silicone also called silicone rubber (long-life implant, no risk of rupture).  Quality control, sterilisation, identification (serial number and patient codification), packaging and shipping to the relevant hospital or clinic. 20/04/2016 7

SURGERY Surgery  Surgery under general anaesthesia, around 1 hour.  3-day hospitalisation maximum  7 cm vertical median incision, preparation of the locus to the size of the implant. Implant deeply placed into the locus under the muscle. Closing in 3 planes. Surgical Outcomes  Surgical outcomes with little pain: simple analgesics.  Little post-operative care: resorbable stitches, no drain, a dressing for only 8 days and a compression bra to wear from discharge for1 month.  Follow-up consultation after 8 days with possible puncture of seroma  Sick leave for 15 days and sports restriction for 3 months . 20/04/2016 8

SURGERY 3D custom-made implant Nuss procedure  Fit perfectly to each patient anatomy, refined aesthetic  Risk of malformation persists after bar removal result, invisible implant.  Risk of bar displacement (urgent additional surgery)  Easy setting up of the implant, excellent stability  2 surgeries of 2 hours, 7-day hospitalisation  Comfort due to material’s flexibility and smooth implant’s  Pain treated with epidural during 4 days and analgesics edges during minimum 1 month, physiotherapy sessions during  Simple surgery : only one surgery of 1 hour, 3-day 1 or 2 months hospitalisation maximum  Back to normal activity after 1 month and sport after 3  Good post-operative outcomes, with mild pain (analgesics months (progressive, contact sports prohibited) during 15 days), control after 8 days  Risks of lesions and complications : pneumothorax,  Rapid resumption of activity (15 days to work and 3 pericarditis, bar displacement, heart and lung damage, months for sport) hematoma…  Low risk of complications, no manipulation of ribs 20/04/2016 9

PECTUS EXCAVATUM RESULTS 20/04/2016 10

POLAND SYNDROME RESULTS 20/04/2016 11

GLOBAL PROCESS Consultation / scan 2 months needed from the quotation Send patient data/ scan (CD) + prescription to Sebbin confirmation and half of the payment to Validate data and feasability implant delivery Send quotation to surgeon W Confirm quotation to Sebbin Surgeon W+1 Launch design, send specifications to surgeon AnatomikModeling W+2 Validate design to AnatomikModeling Sebbin W+3 Manufacture prototype W+4 Manufacture mould W+5 Manufacture by cast of silicone / package implant W 6+7 Send implant to sterilisation W+8 Receive implant and prototype in hospital Perform surgery 20/04/2016 12

BIBLIOGRAPHY Chavoin J.P., Grolleau J.L. , Moreno B., Brunello J., André A. , Dahan M., Garrido I. Chaput B . Correction of pectus excavatum by custom-made silicone implants : Contribution of computer-aided design reconstruction. A 20-year experience and 401 cases . Plast Reconstr Surg. 2016 May;137(5). JP. Chavoin, A. André, B. Chaput, I. Garrido, B. Moreno, M. Dahan , JL. Grolleau Chirurgie des malformations congénitales et techniques de reconstructions assistées par l’informatique. Chirurgie Plastique de l’Enfant et de l’Adolescent, SAURAMPS MEDICAL; 2015 sept 15; p. 252-256 Ho Quoc Ch, Chaput B, Garrido I, André A, Grolleau JL, Chavoin JP. Management of breast asymmetry associated with primary funnel chest Ann Chir Plast Esthet. Elsevier Masson SAS; 2012 Aug 8:1–6. J-P. Chavoin, A.André, E.Bozonnet, A.Teisseyre, J..Arrue, B. Moreno, D. Glangloff, J-L. Grolleau, I.Garrido. Mammary implant selection or chest implants fabrication with computer help ; Ann.de chirurgie plastique esthétique (2010) 55,471-480. André, M. Dahan, E. Bozonnet, I. Garrido, J.-L. Grolleau, J.-P. Chavoin Pectus excavatum : correction par la technique de comblement avec mise en place d’une prothèse en silicone sur mesure en position rétromusculaire profonde Encycl Méd Chir, Elsevier Masson SAS - Techniques chirurgicales - Chirurgie plastique reconstructrice et esthétique, 45-671, Techniques chirurgicales - Thorax, 42-480, 2010. Chavoin JP, Dahan M, Grolleau JL, Soubirac L, Wagner A, Foucras L, Darbas D, Pomar P. Funnel chest : filling technique with deep custom made implant. Ann Chir Plast Esthet. 2003 Apr 48(2) : 67-76. Chavoin JP, Grolleau JL, Lavigne B, Darbas D, Dahan M et Pomard P. Chirurgie des malformations du thorax. Encycl Méd Chir (Elsevier, Paris), Techniques chirurgicales Chirurgie plastique reconstructrice et esthétique, 45-671, 1998, 12 p. Umuroglu T, Bostancı K, Thomas DT, Yuksel M, Gogus FY. Perioperative anesthetic and surgical complications of the Nuss procedure. J Cardiothorac Vasc Anesth. 2013 Jun; 27(3):436–40. Guntheroth WG, Spiers PS. Cardiac function before and after surgery for pectus excavatum . Am J Cardiol. 2007 Jun 15; 99(12):1762–4. Malek MH, Berger DE, Marelich WD, Coburn JW, Beck TW, Housh TJ. Pulmonary function following surgical repair of pectus excavatum: a meta-analysis. Eur J Cardiothorac Surg. 2006 Oct; 30(4):637–43. Chichery A., Jalbert F., Foucras L., Grolleau J.-L., Chavoin J.-P. Syndrome de Poland. 20/04/2016 13 EMC (Elsevier SAS, Paris), Techniques chirurgicales - Chirurgie plastique reconstructrice et esthétique, 45-667-E, 2006.

CONTACT US AnatomikModeling Postal: 19 rue Jean Mermoz, 31100 Toulouse, France Email : contact@anatomikmodeling.com Phone: +33 5 62 83 31 04 Website: www.anatomikmodeling.com 20/04/2016 14