Percutaneous valve repair often is touted as the bold new frontier for surgeons and med-tech companies. The “frontier” adds an assortment of treatment options available to those who suffer from coronary artery disease.
Med-tech start-up Myocor (Maple Grove, Minnesota) already has reported its intentions to embark on the path, with the recent news of the FDA granting conditional approval of the company’s Valvular and Ventricular Improvement Via iCoapsys Delivery (VIVID) feasibility study.
The single-arm study is poised to evaluate the safety and feasibility of the percutaneously implanted iCoapsys system in treating patients with mitral valve insuffiency (leaky valve) caused by left ventricular dysfunction and coronary artery disease (CAD).
“We’re looking at maybe having 15 to 30 patients with up to six centers,” Myocor CEO Jim Hickey told Medical Device Daily. “The study should be completed by 2008.”
Hickey was named CEO of Myocor nearly two years ago (Medical Device Daily, Jan. 26, 2006).
The iCoapsys device and implant procedure are based on the original, surgically implanted Coapsys® system. The first Coapsys device is currently being evaluated in the RESTOR-MV trial. Both devices are designed to reduce functional mitral regurgitation and reshape the left ventricle to provide a more complete reshaping therapy than traditional mitral valve repair. The development of the iCoapsys system will allow Myocor to provide physicians with percutaneous options for their patients, while Coapsys allows for surgical options.
Both devices have two pads with a long cord and resemble a T. Here’s how they work:
The device is implanted so the two pads are located on the surface of the heart with the chord passing across the left ventricle. The posterior pad of each device has a superior (top) and inferior (bottom) head. During the implant procedure, the pads are pulled towards each other to decrease the distance between the mitral valve leaflets and reshape the left ventricle. The Coapsys and iCoapsys devices are designed to provide the same Reshaping therapy via different delivery approaches.
“The total procedure should take about an hour,” Hickey said.
‘Percutaneous valve repair is a new frontier of patient care,” said Wes Pedersen, MD, interventional director, complex valve disorders, at the Minneapolis Heart Institute. “The iCoapsys system offers patients an innovative, less invasive option for treating their functional mitral regurgitation. It is very exciting to be able to participate in the VIVID feasibility study as the principal investigator at Abbott Northwestern Hospital.”
To date valve repair operations have offered new opportunities to patients and med-tech companies have been in a rush to put their special mark on them.
CoreValve (Irvine, California), Edward Life Sciences (Irvine, California) and JenaValve (Munich Germany) have all been reported as major players in aortic valve replacement procedures (MDD, June 5, 2007).
The procedure was ranked No. 2 in the second edition of the Top Ten list of medical innovations for the year, which was presented on the final day of the Cleveland Clinic-sponsored Medical Device Innovation Summit (MDD, Oct. 5, 2007).
With all the attention valve procedures are receiving, this is a perfect time to transverse this market.
“We have been very disciplined in bringing these devices through the design, manufacturing and trial processes with an eye on long-term success,” Hickey said. “We have been fortunate to have the experience of implanting over 120 Coapsys devices worldwide, the dedication of a talented group of employees and clinicians who believe in our therapy, and the backing of a strong investor group.”
Myocor, has been in existence since 1996 and is a privately held company financed through a number of venture capital firms, Hickey said. To date the company has raised $50 million.
Nearly three years ago the company completed a $24 million Series D round of financing led by Prism Venture Partners. Additional investors participating in the round included Affinity Capital Management, Alta Partners, Coral Ventures, Institutional Venture Partners, Investor Growth Capital, St. Paul Venture Capital and Tullis-Dickerson and Co.
At the time the company said this financing would be directed primarily to two key initiatives: to complete the clinical trial of its Coapsys annuloplasty system, a less invasive therapy for the treatment of mitral regurgitation as well as to complete development and initiate the first human clinical trials of Myocor’s next-generation, catheter-based (interventional) technology to treat the mitral valve (MDD, Dec. 22, 2004).
“Because of our backing these are the only two projects [iCoapsys, Coapsys] we’re focused on now,” Hickey said. “We’ve got a lot of ideas on the drawing board – but as for now we’re just focusing on these two.”