Typically patients suffering from mitral regurgitation (MR) have had but two options: surgery, or no treatment at all. One company is working to change that with its MitraClip system, currently being evaluated in the U.S. as a non-surgical repair option for MR.

Evalve (Menlo Park, California) said last month that it had completed enrollment for its Endovascular Valve Edge-to-Edge REpair STudy (EVEREST). The device received CE-mark approval earlier this year and the first series of patients were treated recently in Germany in September. According to Evalve, the MitraClip is the first commercially available treatment alternative that enables non-surgical repair for MR.

"Mitral valve surgery is one of the most traumatic surgeries that cardiothoracic surgeons perform, there is a high morbidity rate associated with it and the sicker the patients are there is a higher mortality risk with it as well," President/CEO Ferolyn Powell told Cardiovascular Devices & Drugs.

Powell said about half of the patients who undergo open mitral valve surgery end up needing to either go to a step-down nursing facility or receive at-home nursing care because they are unable to care for themselves after the surgery. Of the patients who have had percutaneous mitral valve repair with the MitraClip and did not require open surgery later, have all gone home without nursing care, she said.

"The MitraClip system itself is really a novel first-in-class technology and it's enabling interventional cardiologists to repair the mitral valve with a groin stick, basically, versus open heart surgery," Powell said.

MR is the abnormal leaking of blood through the mitral valve, from the left ventricle. It is the most common type of heart valve insufficiency in the U.S., affecting millions of people worldwide, Evalve says.

Physicians in the catheterization laboratory perform percutaneous mitral repair with the MitraClip device. The heart beats normally during the procedure, and therefore does not require a heart-lung bypass machine. In addition to improving blood flow through the heart, the procedure may also relieve symptoms such as fatigue and shortness of breath that often affect patients with significant MR.

After treatment, patients generally recover quickly, the company noted. The MitraClip device may improve quality of life and may help MR patients avoid or delay surgery, having preserved surgical options (valve repair or replacement) should surgery become necessary, Evalve said.

"That was one of the real important things we set out to ensure when we designed and developed the product is that this could be a first line of care for some patients in that if it didn't work, their other options, their surgical options, are preserved," Powell told MDD.

EVEREST is an FDA-approved Phase II randomized, controlled, multi-center clinical research study in the U.S. and Canada evaluating the safety and efficacy of the MitraClip in 279 patients with moderate-to-severe (3+) or severe (4+) MR, as compared to surgical repair or replacement. The study effectiveness endpoint requires an MR reduction to = 2+ at one year. The primary effectiveness endpoint is freedom from surgery for valve dysfunction, death, and moderate-to-severe or severe mitral regurgitation at one year. The primary safety endpoint is freedom from major adverse events at 30 days or hospital discharge whichever is longer.

"The completion of enrollment in the randomized trial is an important milestone for the field of cardiology," said Ted Feldman, MD, director of the cardiac catheterization lab at Evanston Northwestern Hospital (Evanston, Illinois) and co-principal investigator of the trial. "It is the first randomized trial of any percutaneous mitral repair device compared to mitral valve surgery, and also the first large prospective evaluation of current mitral valve surgery using an independent core laboratory."

Overall, EVEREST investigators have treated more than 350 patients with more than 450 MitraClip devices implanted. Clinical data continues to grow, the company noted, and a significant number of three-year follow up results are available as well as four-year data from a smaller group of patients.

"Randomized trials provide valuable insight into directing future studies to improve therapy and match new therapies to the appropriate patient," said Donald Glower, MD, professor of surgery at Duke Medical Center (Durham, North Carolina) and co-principal investigator of the EVEREST study. "This trial sets a high scientific standard for future percutaneous valve therapies. As a result, this trial will have a significant and long-lasting impact on patient care around the world."

Registry data from the initial non-randomized cohort of EVEREST patients continue to indicate MR reduction is maintained over time in the majority of patients, hospital stays are short, fewer complications occur compared to mitral valve surgery and surgical options are preserved if needed.

"This is an important achievement for Evalve on the path to meeting regulatory milestones with the FDA," Powell said. "We believe the MitraClip system has the potential to provide patients suffering with MR an important alternative to surgery that will allow them to avoid the associated risks and trauma."

Prosthetic vein valve developed for CVI

Some day, doctors will be able to tap into vast warehouses for virtually every human body replacement part – or create custom-made tissue and organs as needed. As part of that effort, engineers at Georgia Institute of Technology (Georgia Tech; Atlanta) are working to develop what may be a more obscure, if not necessary part of the human inventory: prosthetic vein valves for patients suffering from chronic venous insufficiency (CVI).

CVI is a condition which affects more than 7 million people in the U.S. that occurs when valves in a person's veins can no longer ensure a one-way flow of blood back to the heart.

Valves in the veins usually push the flow of blood up toward the heart. But when they're damaged, blood leaks and pools in the legs and feet and results in CVI. Compression stockings and devices - along with anticoagulants and bed rest - are the most advanced treatments available today.

While it's not life threatening for most people unless infection ensues, "CVI makes their lives miserable," David Ku, MD, the Lawrence P. Huang Endowed Chair in Engineering and Entrepreneurship and Regents' Professor in the George W. Woodruff School of Mechanical Engineering at Georgia Tech, told CD&D in September.

With a background in vascular surgery, Ku said he saw a lot of patients with this condition and current treatments don't fix the problem.

"Most people get compression stockings and they provide symptomatic relief, but often there's still skin breakdown and infection that can be pretty nasty," he said. "The skin tends not to heal without good blood flow."

Blood normally flows to the toes because of gravity, but the body uses vein valves to pump blood in one direction back to the heart. Problems with these little valves start when they dissolve away after a blood clot. The loss of the valve leaflets allows blood to flow the wrong way, causing swelling in the legs and ankles.

Symptoms can also include dull, aching, heaviness, or cramping in legs, itching and tingling, pain that's worse when standing, redness of legs and ankles, skin color changes around the ankles, superficial varicose veins, thickening of the skin on legs and ankles and ulcers on the legs and ankles.

Some surgical options are available to repair or replace damaged vein valves, including valve transplantation. But Ku believes that replacing the valve with a prosthetic one is likely to be a better option because finding a suitable donor valve in one of the patient's legs can be challenging to difficult.

Ku and his collaborators are developing a valve made of poly cryogel, a material patented by Georgia Tech in 1999. The material is biocompatible with body tissue because of its attraction to water, the ability to adjust its mechanical strength, flexibility comparable to that of natural body tissue and composition of organic polymer, rather than silicone.

Classified as a hydrogel, Salubria contains water in similar proportions to human tissue and can be processed to be similar in its mechanical and physical properties. The organic polymer-based biomaterial is known to be biocompatible. Although it is soft and compliant like human tissue, it has been formulated to be wear-resistant and strong.

To date, Ku and team have implanted the valves in sheep cadavers. They are now launching into live animal studies. Sheep were chosen because their cardiovascular geometry and physiology are similar to those of humans. Assuming the animal studies go well, Ku envisions licensing the technology to a company.

"To my knowledge there are no prosthetic valves in clinical studies or on the market today," he said. "The makers of heart valves have designed similar valves and described them in the literature. Most have been made of metal or hard plastic, but they tend to erode over time and the vein is very thin."

Paragon becomes Nexeon, gets $24M

Last month marked the beginning of a new era for Paragon Intellectual Properties (Charleston, West Virginia) as the company reported it had restructured, moving from a limited liability company with seven subsidiaries to a single C-corporation to form Nexeon MedSystems. The company said the change was made to prepare for clinical trials and commercialization of its lead technologies.

But wait, that's not all: The company also reported raising a $24 million round of financing and kicking off a first-in-man trial to evaluate its Protex coronary stent.

"I founded the company as a way to house some of my personal intellectual property and build out to create value, moving forward, where today we're looking at a potential legacy company that has multiple products," Mark Bates, MD, Nexeon CEO, told CD&D. "We've been on budget, on track … we've hit every clinical milestone along the way."

Bates also is a professor of medicine and surgery at West Virginia University (Morgantown) and a leading interventional cardiologist at CAMC Vascular Center of Excellence (Charleston). He said the company has come a long way since 2005 when it had just two employees, compared to the 25 employees it has today.

"What's become exciting to us is [that] our forward momentum has exceeded everyone's expectation," Bates said.

Nexeon said it plans to use the financing proceeds to support a clinical trial of its Protex heart stent, a device designed to overcome the pitfalls associated with both bare-metal and drug-eluting stent systems.

If one thing sets Nexeon apart from other companies, Bates said, it is a "physician-driven end-user innovation mindset."

The Protex system integrates Nexeon's low-profile (0.86 mm) cobalt alloy stent platform with the Finale prohealing extracellular matrix coating supplied by SurModics. Bates said the stent's unique design and its protein coating – intended to accelerate the healing process – set it apart from other heart stents on the market. The system is designed to reduce or eliminate rates of late stent thrombosis, a complication sometimes associated with DES devices, and that of restenosis – the re-narrowing of the stented vessel – which occurs in about 20% of BMS procedures.

Also, the company noted, the Protex stent system may eliminate the need for long-term antiplatelet therapy. The device is the result of a collaboration between Nexeon and SurModics, reported last year.

KineAssist benefits stroke patients, therapists

For a recovering stroke patient, no one person may be more important than the physical therapist devoted to rehabilitating the body. This "relearning" of the physical functions of life can be frustrating for the patient; fear of slipping or falling during training sessions is ever-present.

Once the patient is hooked up to an exercise system, there is only so much hands-on treatment a therapist can do (other than monitor the repetitive motions of the exercise machine).

But now, patients learning to walk again after a stroke and neurological injuries are benefiting from a new device in the KineAssist Robot, made by Kinea Design (Evanston, Illinois), which represents a giant leap forward in effectiveness for people learning to walk again after a stroke or neurological injuries.

The robot, the first of its kind to be used in a community-based hospital setting, was demonstrated recently at Alexian Rehabilitation Hospital (Elk Grove Village, Illinois). A new prototype of the robot is being introduced following three years of successful clinical trials at the Rehabilitation Institute of Chicago (RIC) to refine and fine-tune its unique features and capabilities.

The KineAssist Walking & Balance Exercise System was developed through a joint venture of Kinea Design, the RIC and Chicago PT.

Dave Brown, a co-founder of Kinea Design, told CD&D that he likes to think of the device as a "cobot." By this, Brown means that "the robot is driven by the intentions of the user and the therapist. There are four motion sensors that can pick up individual movements of the patient. It allows the therapist to directly assist in the movement of the patient . . . not just be a bystander as the machine goes through repetitive motions with a patient [compared to other rehabilitation devices]."

The KineAssist uses its robotic technology to help patients learn to walk forward and backward, step sideways, climb stairs and regain the balance, strength and mobility to carry on daily activities without the fear of falling.

The robot frees up therapists allows them to interact with and safely challenge patients with real-life tasks, while the robot fully supports and holds patients in a safe position even if they lose their balance.

The harness on the robot was designed by the same team that designs harnesses for Cirque du Soleil. The patient is secured with upper and lower straps and allows for full body weight-supported treadmill training.

Therapists can adjust the robot's level of resistance and other variables by touch screen, a new level of control for therapists as they help patients progressively build strength and flexibility. The KineAssist's computer screen also displays patient performance data for therapists and patients to measure their progress.

Angiotech contemplates major restructuring

Angiotech Pharmaceuticals (Vancouver, British Columbia) reported plans last month to cut jobs, close a plant and delay a new product. It also may drop a financing deal and will withdraw offers to buy outstanding notes. The actions follow a cost-cutting plan reported in April, company said in a statement. Further steps were needed, Angiotech said. The company has been hobbled by declining sales of drug-eluting stents by partner Boston Scientific (Natick Massachusetts).

The company's manufacturing and research center in Rochester, New York, will be closed in December 2009, and Angiotech said it will postpone the scheduled introduction of a drug-coated catheter, the 5-FU CVC. Office and laboratory space will be cut or eliminated in Vancouver, as well as in North Bend, Washington, and Herndon, Virginia.

Additionally, the company said it has doubts whether it can complete its previously reported arrangement with the investment management firm Ares Management, and the venture capital firm New Leaf Venture Partners. Angiotech reported in July that it would sell $200 million to $300 million in convertible notes to Ares and New Leaf in an effort to form a new operating unit and reduce debt.

The company said it "plans to withdraw its outstanding tender offers for its senior floating rate notes and its senior subordinated notes." The company also said Ares and New Leaf do not support its reorganization plans.

At the time the financing disclosure was made back in July, the company said the new subsidiary would hold most of its assets outside of its Taxus coronary stent business, a product sold by Boston Scientific for which Angiotech provides the paclitaxel drug coating. The new unit was to be called Angiotech Pharmaceutical Interventions.

"Our board of directors believes that despite the growth and progress we've seen this year in our medical products businesses, it is in the best interest of Angiotech and its shareholders to take action now to adjust our business and operating structure in order to achieve cost savings and to further focus our business initiatives," CEO Dr. William Hunter said in a statement.

GE, Boston Scientific in ultrasound deal

GE Healthcare (Waukesha, Wisconsin) and Boston Scientific reported at last month's Transcatheter Cardiovascular Therapeutics conference a collaboration focused on improving intravascular ultrasound (IVUS) workflow between GE's Innova Cardiovascular X-ray System and Boston Sci's iLab Ultrasound Imaging System.

GE Healthcare says that the Innova help physicians to visualize fine vessels, precisely place stents and perform critical procedures. Cardiologists use it when performing procedures in the cath lab to view and treat potential coronary artery blockages that could cause heart attacks or other cardiovascular damage.

Jayant Saha, general manager, interventional global marketing for GE Healthcare, said, "IVUS has proved to be an important and indispensable diagnostic tool in interventional cardiology. Boston Scientific, a leading IVUS solutions provider, and GE look forward to offering the technological advances in the field of IVUS to our joint customers."

The iLab Ultrasound Imaging System can be directly installed into the cardiac catheterization lab or radiology suite alongside the GE Innova X-ray System, enabling physicians to readily incorporate IVUS technology into their procedures. With IVUS, a tiny catheter is inserted into the heart or into a vessel where high-frequency sound waves reflect off tissue or vessel walls. The reflected sound waves create a cross-sectional image from within the vessel or heart to aid in visualizing vessel and heart structure.