Oticon Medical Gains FDA Clearance For Two New Offerings: Minimally Invasive Ponto Surgery (MIPS) And Ponto BHX Implant

SOMERSET, N.J.--(BUSINESS WIRE)--Oticon Medical announced today that the US Food and Drug Administration has cleared two new Oticon Medical offerings for marketing in the US. New Minimally Invasive Ponto Surgery (MIPS), performed with minimal skin penetration and less interference to soft tissue than ever before, is a further refinement of the proven tissue preservation surgery for use with the company’s Ponto System. The new Ponto BHX Implant is the first implant with a laser-ablated titanium surface that promotes a faster and stronger bonding to bone and increases the strength of the bone-to-implant interface by more than 150%.

“We want people to know that when they choose Oticon Medical, they are choosing a company that will continue to provide innovative solutions that improve quality of life now and in the future.”

“The new Minimally Invasive Ponto Surgery and the Ponto BHX Implant are excellent examples of how Oticon Medical innovation creates new benefits and exciting synergies with our proven products,” says Oticon Medical President Jes Olsen. “We want people to know that when they choose Oticon Medical, they are choosing a company that will continue to provide innovative solutions that improve quality of life now and in the future.”

MIPS: A Truly New Perspective on Tissue Preservation

Minimally Invasive Ponto Surgery aims to reduce the risk of any complications following surgery by minimizing the surgical intervention. 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 leaves the patient’s blood supply, micro circulation and nerves as intact as possible. The suture-free surgery enables improved cosmetic outcomes for the patients, with no scar formation around the abutment site.

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 state-of-the-art drill system delivers a bone- and tissue-friendly system setup for surgical control and precise tactility.

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.

Ponto BHX Implant: Stronger than Bone, Highest Stability

The Ponto BHX Implant is a perfect match between Oticon Medical’s proven OptiGrip™ geometry and the latest surface technology, taking osseointegration to the next level – bone bonding – and delivering the highest stability from day one.

The new implant builds on the proven OptiGrip geometry. The Wide Ponto implant with OptiGrip™ geometry has the highest level of initial stability of all bone anchored implants. Ponto BHX implants improve the biomechanical fixation even further and, at the same time, promote a faster and stronger bonding to the bone.

An innovative site-specific laser modification at the roots of the threads of the OptiGrip™ geometry 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, the first laser-ablated titanium surface, offers additional benefit, aiming to lower the loss rate among children and adults with soft and compromised bone.

Designed for Tissue Preservation Surgery

Oticon Medical offers the most extensive family of abutments for variation in skin thicknesses, all ideally suited for Minimally Invasive Ponto Surgery. The flexible Ponto abutment family pre-mounted with the Ponto BHX implant is ideal for use in minimally invasive surgery. The even, supportive surface and perfectly matched interface of Ponto abutments create an optimized fit that leaves no pockets or pathways where skin needs to grow back or where bacteria can collect.

For more information about Minimally Invasive Ponto Surgery, visit www.oticonmedical.com/mips and www.oticonmedical.com/mipsvideo. More information about the Ponto BHX Implant and the entire family of Ponto abutment family can be found at www.oticonmedical.com/bhx.