NeoChord wins FDA nod for mitral valve repair trial

May 13, 2016 By Brad Perriello Leave a Comment

NeoChord said it won an investigational device exemption from the FDA for a clinical trial of its mitral valve repair technology.

St. Louis Park, Minn.-based NeoChord said the 20-site study is a prospective, multicenter, randomized clinical trial of its DS1000 artificial chordae delivery system.

“IDE approval is a major milestone for NeoChord and its investors,” president & CEO David Chung said in prepared remarks. “This technology has demonstrated excellent outcomes in reducing mitral regurgitation in both clinical studies and commercial use outside the U.S., and we expect to demonstrate the same excellent results in our U.S. pivotal study. We look forward to making this transformational technology available to patients in the U.S.”

“We are excited to begin our FDA approved pivotal trial at 20 U.S. mitral repair centers,” added VP of clinical, regulatory & quality Lori Adels. “This is the first U.S. clinical study of a trans-apical, beating heart procedure for replacement of ruptured or elongated chordae in patients with degenerative mitral valve regurgitation. The protocol was developed in consultation with the FDA and our Principal Investigators, David H. Adams, MD, Professor and Chairman, Department of Cardiovascular Surgery, Icahn School of Medicine at Mt. Sinai, New York, and Michael A. Borger, MD, PhD, Professor and Director, Cardiovascular Institute, New York Presbyterian/Columbia University Medical Center, New York, and is designed to establish the safety and efficacy of the DS1000 System as an alternative to standard surgical mitral valve repair.”

In June 2015, the company raised $12.6 million of a hoped-for $20 million debt round to support the DS1000 device, which is designed to allow the implantation of artificial chordae tendinae, thread-like connectors that anchor leaflets of the mitral valve to heart muscle. Doctors can use the device to repair mitral valve prolapse via a transapical, off-pump procedure.

Last year, Neochord replaced president & CEO John Seaberg with Chung, an Edwards Lifesciences (NYSE:EW) veteran.

Neochord won CE Mark approval in the European Union for the device in late 2012, but has not yet won FDA clearance of the device. The company reports that more than 100 patients across Europe have been treated with the device.

Siemens Healthineers lands FDA clearance for two CT systems
Siemens Healthineers this week said it won FDA clearance for its Somatom go.Sim and Somtom go.Open Pro computed tomography systems. The CT systems are designed for radiation therapy planning and are members of the company’s Somatom go. platform of devices. Siemens Healthineers’ platform uses hardware and software components like patient marking lasers and automated quality… […]
Protolabs’ healthcare grant spurs 2 feeding tube inventions
Digital manufacturer Protolabs (NYSE:PRLB) announced today that MedStar Health (Columbia, Md.) and Cleveland Clinic Innovations are joint winners of the company’s Cool Idea Award: Healthcare Grant. These grants provide in-kind manufacturing services to the support development of medical products to spur innovation in the field. MedStar Health’s gravity-feed syringe holder simplifies the feeding of newborns who spend […]
Sterigenics’ legal troubles mount in Illinois
Nearly two dozen new lawsuits were filed against Sterigenics this week over its now-shuttered ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., according to a law firm representing some of the plaintiffs. That brings the total of such lawsuits to nearly 75, noted Chicago personal injury lawyer Antonio Romanucci, court-appointed lead counsel from among five… […]
In2Bones launches AlloAid BioNail
In2Bones this week launched its AlloAid BioNail sterile allograft implant. The implant is designed to give rigid, stable fixation during hand and foot reconstruction. AlloAid BioNail is made from strong cortical allografts to provide osteoconductive properties for bone remodeling and healing. It features a tapered point and multiple, contoured wedge facets to ease insertion, anchor… […]
Protolabs’ healthcare grant spurs 2 feeding tube inventions
Digital manufacturer Protolabs (NYSE:PRLB) announced today that MedStar Health (Columbia, Md.) and Cleveland Clinic Innovations are joint winners of the company’s Cool Idea Award: Healthcare Grant. These grants provide in-kind manufacturing services to the support development of medical products to spur innovation in the field. MedStar Health’s gravity-feed syringe holder simplifies the feeding of newborns… […]
Nihon Kohden launches new patient monitor
Nihon Kohden (TYO:6849) announced the U.S. launch of its Life Scope SVM-7200 series vital signs monitor for outpatient facilities and beds that aren’t continuously monitored. The Life Scope SVM-7200 is designed to provide customizable early warning scoring to help clinicians identify patients who are deteriorating or at risk of deterioration. It combines vital signs data with… […]
Senate confirms Dr. Stephen Hahn to lead FDA
The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer at Houston’s… […]
3M to sell drug-delivery biz to Altaris Capital Partners for $650m
3M (NYSE:MMM) announced today that it entered into an agreement to sell most of its drug-delivery business to an affiliate of Altaris Capital Partners for approximately $650 million. St. Paul, Minn.-based 3M will retain its transdermal drug delivery components business, according to a news release. The business being divested has annual global sales reaching approximately… […]
Lawsuit endangers Sterigenics consent order in Georgia
A consent order that Sterigenics entered into with the state of Georgia to reduce ethylene oxide (EtO) emissions at its Atlanta medtech sterilization plant may be in jeopardy. A hearing is scheduled today on a lawsuit that accuses the Georgia Environmental Protection Division (EPD) of failing to take public comment before entering the Aug. 7… […]
Trelleborg acquires Tritec Seal
Trelleborg Sealing Solutions said today it has closed on its acquisition of rotary seal manufacturer Tritec Seal, which produces engineered polytetrafluoroethylene (PTFE) sealing solutions. Trelleborg said the acquisition strengthens its product portfolio while giving the business area access to increased manufacturing capacity. Headquartered in Fenton, Mich., with additional manufacturing in Giddings, Texas, Tritec Seal generated… […]
RSNA 2019: 7 radiology innovations you need to know
Nearly 53,000 people attended the 2019 Radiological Society of North America annual meeting in Chicago last week. And they heard the same acronym over and over again: AI. Exhibitors at the conference touted their artificial-intelligence-enhanced technology at every turn, claiming to make images clearer, sharper, easier to use and powerful enough to help clinicians make… […]