The FDA has cleared two new Oticon Medical products for marketing in the US. The new Minimally Invasive Ponto Surgery (MIPS), performed with minimal skin penetration and less interference to soft tissue than before, is an update of the tissue preservation surgery for use with the company’s Ponto System. The new Ponto BHX Implant has a laser-ablated titanium surface that promotes a faster and stronger bonding to bone, and is designed to increase the strength of the bone-to-implant interface by more than 150%.
Oticon Medical recently introduced the Ponto BHX Implant, which has been FDA-cleared, and includes OptiGrip™ geometry to provide a high level of initial stability in bone anchored implants. A site-specific laser modification at the roots of the threads of the OptiGrip creates a three level surface topography matching the natural bone structure at the macro-, micro- and nano-scale promoting bone-bonding and interface strength. In fact, the bone bonding to the BHX Implant is stronger than bone itself. The enhanced osseointegration provided by the Biohelix surface offers additional benefit, aiming to lower the loss rate among children and adults with soft and compromised bone.
Ponto BHX implants are said to improve the biomechanical fixation and, at the same time, promote a faster and stronger bonding to the bone.
“The unique Biohelix™ surface is the outcome of the latest research from experts of osseointegration in Gothenburg, Sweden,” said Oticon Medical President Jes Olsen. “By building on Brånemark osseointegration technology’s 40 years of excellent clinical results, we aim to improve clinical outcomes in patients with soft or compromised bone as well as offer increased implant stability margins for regular patients.”
The flexible Ponto abutment family pre-mounted with the Ponto BHX implant is suitable for use in minimally invasive surgery. Oticon Medical reports that it offers an extensive family of abutments supporting different skin thicknesses. All abutments have a pure titanium surface and the OptiFit geometry, which has been scientifically proven for tissue preservation surgery.
Announced at the same time, Oticon Medical introduced a refinement of its tissue preservation surgery for use with the company’s Ponto System. The new FDA-cleared Minimally Invasive Ponto Surgery (MIPS) is said to offer a reduced level of intervention that aims to minimize post-op complications. A minor punch incision removes only the soft tissue that corresponds to the shape of the Ponto abutment. The suture-free surgery enables improved cosmetic outcomes for patients, with no scar formation around the abutment site.
“For patients and surgeons, tissue preservation has been one of the most important surgical developments in bone anchored hearing in terms of quicker surgery, shorter healing time, and less numbness and pain,” said Olsen. “With Minimally Invasive Ponto Surgery, we provide a truly new perspective on tissue preservation with strong patient benefits–suture-free surgery with no scarring and fewer post-op complications.”
Minimally Invasive Ponto Surgery aims to reduce the risk of any complications following surgery by minimizing the surgical intervention, says the company. The new surgical technique is performed with a minor incision without scar formation around the site. Only the soft tissue that corresponds to the shape of the Ponto abutment is removed. By maximizing tissue preservation, MIPS is designed to leave patient’s blood supply, micro circulation, and nerves as intact as possible.
A complete kit of new surgical components have been tailor-made to support Minimally Invasive Ponto Surgery. The core of the new instrumentation is the cannula that, together with the new drill system, delivers a bone- and tissue-friendly system setup for surgical control and precise tactility. The full drilling procedure is performed through the cannula, which protects the soft tissue and holds the cooling fluid during drilling. The new drills are designed for more efficient drilling with a twist drill design that helps remove bone chips from the drilled hole and also allows cooling fluid to reach the bone. The implant insertion is guided by the insertion indicator that supports the operator in judging when the implant is fully seated. The new soft healing cap is fitted to stay in place during the short healing period.
The company reports that 16 clinics in 6 countries participated in an evaluation of MIPS. The evaluation involved surgeons who currently perform BAHS surgery, all experienced in tissue preservation techniques. At the conclusion of the trial, 94% of the participating surgeons indicated that they would continue to use MIPS, and 87% reported that they believe the new surgical technique provides further benefits for patients. Post-operative patient response to the new surgical procedure was overwhelmingly positive.
A large multi-center randomized control clinical trial of MIPS is ongoing under the lead of Professor Stokroos and his team at Maastricht UMC+. The results of the trial are expected during 2016. Based on the initial experience and the training of the surgeons, Stokroos reported that the new MIPS technique is a clear, simple and fast surgical procedure that is easy to learn. With no need for sutures, and no incision scar, the single-stage MIPS provides favorable cosmetic results.
MIPS is recommended for adult patients with normal bone quality and bone thickness above 3 mm, where no complications during surgery are expected. MIPS may also be suitable for children with normal bone quality and bone thickness above 4 mm, typically 12 years or older. For more information about the Ponto BHX Implant and the entire family of Ponto abutments, visit the Oticon Medical website.
Source: Oticon Medical