BB&Ts

Doing business in med-tech is at once both complicated and simple. As an example of the latter, a nod from the FDA is all a company needs to make some serious headway in the market.

Take Cardica (Redwood City, California) for example. Shares for the California-based company shot up more than 35% at $10.70 a share on the same early September day it issued a press release noting 510(k) clearance to market its PAS-Port Proximal Anastomosis System for use in cardiac bypass surgery in the U.S.

Until now, the system was limited to sales in Europe and Japan, but FDA approval opens up a floodgate of patients who're looking for a safer, less-intrusive means of cardiac bypass surgery.

"With the introduction of the PAS-Port system in the U.S., cardiothoracic surgeons are now provided with a complete package of reliable, automated revascularization systems for use in CABG procedures," President/CEO Bernard Hausen, MD, PhD, said during a conference call. He added, "We believe that by replacing hand-sewn sutures, our automated proximal and distal anastomoses systems can help cardiovascular surgeons perform consistent, reliable anastomoses with even the smallest of vessels, giving surgeons greater ability to use minimally invasive techniques for cardiac surgery."

Hausen said Cardica plans to launch PAS-Port in the U.S. in the next several weeks with "a systematic and deliberate roll-out to surgeons and [we] look forward to training 50 to 60 surgeons per quarter, as we previously have discussed."

The device creates a secure connection between the body's main artery and vein grafts. It differs from the current method of connecting a bypass graft vessel to the aorta in CABG surgery, which often requires that the aorta be clamped and utilizes time-consuming, hand-sewn sutures. When the clamp is released, tiny blood clots or particles from the aortic wall can be released, which can travel to the brain and cause stroke and other neurologic complications.

The company said the PAS-Port system allows a surgeon to complete an automated proximal anastomosis without the need to clamp and manipulate the aorta. Eliminating the clamp may greatly reduce the risk of particle release and ensuing neurocognitive events, it said. Put another way, this means an attachment to a vessel of 3 mm or more in diameter, using a clamping or "coupling" approach, compared to connection to a vessel of just 1 mm in diameter, using the delicate stapling method.

"PAS-Port leaves no metal or aluminum in the graft and it reduces occurrences of restenosis," Hausen said, calling the device a "major milestone". The system's design allows surgeons to load the bypass graft into the system and rapidly complete the anastomosis, typically in about a minute. This reduces the time required for the anastomosis while providing a consistent, reliable connection. The bypass graft is loaded into the system without damaging endothelial cells, while maximizing the orifice, which is especially important with a small graft. No metal is within the lumen of the graft vessel.

According to results from the pivotal clinical trial of the PAS-Port system, anastomosis surgical time is significantly reduced compared with hand-sewn anastomoses. Patient outcomes may be improved due to shortening of surgery times and hospital stays and reducing complications associated with aortic clamping. Cardica conducted a 220-patient, prospective, pivotal, randomized trial of PAS-Port at 12 sites in the U.S. and Europe. The trial compared venous bypass graft vessel connections to the aorta made using the PAS-Port system versus those made using conventional hand-sewn sutures. Results showed that the study met its primary endpoint of non-inferiority to hand-sewn anastomoses, as well as all other primary and secondary endpoints.

Edwards tips scale to tissue over mechanical

It's not exactly the "paper or plastic?" debate, but choosing to go with a mechanical or tissue valve replacement is a question that patients with mitral valve failure must ponder. Until recently the popular choice has been to go with mechanical valves, since the devices provide strength and durability. But there are drawbacks to taking the artificial route the mechanical device makes a loud ticking noise and patients often must take anticoagulation medicines to prevent clotting. And the tissue valve replacement — which usually comes from pigs — route can be even less promising, because it is significantly weaker and can tear easily.

However, Edwards LifeSciences (Irvine, California) is hoping to add a new dimension to the debate with its newly FDA-approved Carpentier-Edwards Perimount Magna mitral heart valve. Last month's approval comes three years after the tissue based-device was given the green light in the European market and is slated to be thrust into the U.S. market, where there are nearly 40,000 mitral valve replacements a year.

"Instead of using the pig tissue, we're using bovine pericardial tissue," Donald Bobo Jr., Edwards' vice president for heart valve therapy, told BB&T. "The bovine tissue is stronger." He said there are two main reasons why pig tissue valve replacements have become so contentious.

"The [problem] is that first, the tissue can calcify and close the valve," Bobo said. "Second, the leaflet tissue is pliable and is easier to tear. The bovine tissue is much stronger and can still calcify but it there aren't many occurrences of that happening. But we do have therapies to prevent calcification." He added that the Carpentier-Edwards ThermaFix process is an anti-calcification technology that was developed to help mitigate tissue valve leaflet calcification, one of the primary causes of tissue valve deterioration.

The company said that the Perimount Magna valve is the first mitral tissue valve to feature an asymmetric shape that mimics the native mitral anatomy. This design advancement, which it termed "significant and unique," provides what it said is the lowest effective profile and lowest ventricular projection for any tissue mitral valve in the industry. In addition, the replacement valve is designed specifically to optimize patient blood flow and facilitates placement above the patient's native valve opening, which may allow surgeons to implant a valve that is larger than other conventional tissue valves.

'Adjustable' annuloplasty repair is FDA-cleared

MiCardia (Irvine, California), a company developing smart implants to treat heart valve disorders that use radio frequency (RF) energy to re-shape the device during or after the implant procedure, received FDA 510(k) clearance last month for two of its products. The FDA cleared its Dynaplasty Annuloplasty Band DR and Annuloplasty Ring DR. These are the first of the company's products under its Dynaplasty brand to receive U.S. market clearance.

MiCardia said the technology is designed for the percutaneous and non-invasive treatment of structural heart disease, including mitral valve regurgitation (MVR), tricuspid valve regurgitation and congestive heart failure (CHF). According to the company, its technology provides devices that can be implanted into the heart and then "dynamically" adjusted, with a less-invasive method, either during or after a procedure for the proper shape and size to produce the best clinical outcome both at the time of the procedure or at subsequent post-operative intervals. It says that the necessary modifications to shape and size can be viewed by ultrasound and then "activated" in real time without requiring additional invasive surgery. According to the company's website, the activation method involves accessing the implanted ring via a percutaneous femoral vein introduction and applying energy to the ring.

Paul Molloy, CEO of MiCardia, said in a statement, "This is a key regulatory milestone for MiCardia which involved extensive technical validation of the company's first generation annuloplasty system. It prepares the way for the progression of this highly unique and innovative Dynaplasty Technology and pairs with the commencement of the company's DYANA Phase I human study in Europe." He added: "To our knowledge, MiCardia is the only company developing intra-operative, percutaneous and completely non-invasive, dynamically adjustable, implantable devices for the $15 billion annual CHF market."

Spectranetics served a search warrant by FDA, ICE

Spectranetics (Colorado Springs, Colorado) was jointly served by the FDA and U.S. Immigration and Customs Enforcement (ICE) in early September with a search warrant issued by the U.S. District Court, District of Colorado. In a statement, the company said that the government requested information and correspondence relating to products used in the treatment of in-stent restenosis, such as catheter guidewires and balloon catheters, manufactured by certain third parties outside of the U.S.

The company said that federal authorities also were seeking information on two post-market studies completed during the period from 2002 to 2005 and payments made to personnel in connection with those studies, as well as on compensation packages for certain company employees.

Spectranetics, which employs 470, including nearly 300 in Colorado Springs, said it is cooperating fully with the appropriate authorities regarding this matter, adding that it currently expects that business operations will continue in the ordinary course.

Charles Chon of Goldman Sachs (New York), whose firm coincidentally on the day of the federal search recommended that investors sell their stock in the company because of increased competition in the laser atherectomy market, said in a research note that the investigation could cause changes in sales or marketing that might hamper Spectranetics' competitiveness or lead to greater spending, disrupt product supplies or cause key company personnel to leave. Lawsuits, fines or penalties also could result, he said, although he added that it is too early to determine the outcomes of the investigation.

Another analyst, Jason Mills of Canaccord Adams (Vancouver, British Columbia) said he believes the company's assertion that business will continue as usual is off the mark. "We do not think the company has its arms around this investigation," he wrote in a research report, adding that the investigation "comes at an inopportune time for Spectranetics in a competitive atherectomy space."