CHALLENGE
Design an innovative new device for less invasive mitral valve surgery, allowing surgeons to operate on patients who are too ill to survive an open-heart procedure
OUTCOME
A novel device that allows surgeons to access the heart between the ribs – leaving the ribcage intact – resulting in safer surgeries and improved patient outcomes.
One in five people over the age of 55 have some degree of mitral valve regurgitation. Left untreated, blood flows backward into the heart, resulting in cardiac failure. Many who suffer from this condition opt out of treatment, as they are often too ill to survive an invasive open-heart surgery.
Giovanni Speziali, MD, a cardiac surgeon at Mayo Clinic, proposed a solution that would enable surgeons to access the heart through the ribs and repair the damaged valve, leaving the ribcage intact. NeoChord, Inc., a Minneapolis-based medical technology start-up, obtained an exclusive license for D. Speziali’s technology and partnered with Worrell to develop the device.
Worrell’s researchers began by conducting an operative immersion, documenting preliminary feedback from surgeons performing similar procedures on animal specimens. Back at the studio, Worrell designers created a test fixture to simulate the procedure and experimented with various physical design concepts. The leading concepts were reintroduced into the field as behavioral prototypes and evaluated by renowned Mayo surgeons. The refined design concepts included a tip, ideally shaped for easy insertion through the chest plate and into the beating heart, allowing surgeons to locate the mitral leaflet, place a suture with accuracy, and repair the damaged valve.
Worrell’s engineers prepared the leading design concept for full-scale manufacturing. Our team introduced NeoChord to key manufacturing and supply chain vendors and their collaborative efforts resulted in a product that was cost-effective and easy to manufacture.
Worrell also supported NeoChord’s graphic design assets, which included branding, logos, and packaging design. Worrell’s efforts in navigating the complexity of the regulatory pathway turned a novel idea into an established medical brand positioned for long-term success.
UPDATES
Due to a considerably less invasive procedure, the NeoChord surgical method is predicted to reduce mitral valve surgery hospital stays from eight days to two. This surgical method already shows an acute procedure success rate, which is greater than 96% in patients with favorable anatomy. Neochord’s surgical method received regulatory approval in the European Union in December 2012, and on April 4, 2014 announced the treatment of their 100th patient.
