Medical Device Daily Associate Managing Editor

Continuing its recent surge of activities, MedicalCV (Inver Grove Heights, Minnesota) yesterday reported that it has submitted a 510(k) application to the FDA seeking clearance for its Atrilaze minimally invasive system for the potential treatment of atrial fibrillation (AF) in a closed-chest beating heart setting. The submission marks a key point in the company's transition from a previous focus on heart valves to cardiovascular therapy via ablation.

The Atrilaze is a laser-based system designed to enable access to and ablation of cardiac tissue including AF, an erratic heartbeat and is the most commonly occurring cardiac arrhythmia. AF alters normal cardiac function, is a major precursor to congestive heart failure and is associated with an increased incidence of stroke.

The company also reported the appointment of a new CFO (see People in Places, page 10). It also recently filed for an initial public offering (IPO) of about $30 million and has filed an application with Nasdaq for a concurrent listing of its common stock on the Nasdaq Capital Market (Medical Device Daily, May 23, 2006).

“We have successfully submitted our Atrilaze 510(k) application to the FDA within our publicly announced timeframe and are excited about the opportunity our differentiated device has to address the unmet needs of the large and growing cardiac ablation market,” said Marc Flores, president and CEO of MedicalCV in a company statement.

Despite making a public release available about the new Atrilaze filing, Flores declined offering additional comment to Medical Device Daily, saying that the company was in a quiet period pending the outcome of the IPO.

According to the company statement, there are currently four primary treatments for AF utilizing drugs, implantable devices, catheter-based treatments and open-chest surgery. The company said it believes its Atrilaze system will allow surgeons to complete an ablation procedure that will produce lesions that closely mimic those obtained by using the classic Maze surgical procedure, which is the current standard of care.

The company believes this procedure could take as little as one to two hours. Using the Atrilaze procedure, surgeons will access the heart through three minimally invasive 1 cm incisions and will utilize an automated laser guide and software-driven ablation sequence, which should last 15 minutes or less.

MedicalCV also believes the pre-programmed and automated nature of the system makes it easy-to-use and minimizes the potential for surgeon error.

“In contrast to the existing, lengthy, invasive surgical and catheter-based treatments,” said Flores, “we expect that the ablation procedure utilizing our Atrilaze system can be completed in one to two hours, with less pain to the patient, and a shorter recovery period.” He added that the company also believes that the system can “significantly and positively impact the marketplace, by providing the first, truly standalone, closed-chest beating heart procedure for cardiac tissue ablation that has the potential to treat AF.”

In its IPO filing the company acknowledged that it faces some rather stiff competition in the market to develop cardiac ablation systems including such companies as AtriCure (West Chester, Ohio), Boston Scientific (Natick, Massachusetts), CryoCath Technologies (Montreal), Edwards Lifesciences (Irvine, California), Medtronic (Minneapolis), St. Jude Medical (St. Paul, Minnesota),Johnson & Johnson (New Brunswick, New Jersey) and Cardima (Fremont, California).

The company also noted as an additional risk factor that it received a letter from Edwards Lifesciences concerning its Atrilaze system. While it said that Edwards did not claim that the company's products infringe any of its patents, Edwards' letter called attention to six of its patents and requested that Medical CV comment on how its products differ from the claimed methods and apparatus of the six specified Edwards patents. The company said it does not believe that its Atrilaze system infringes any of the Edwards patents.

According to published data, it is easy to see why the company would take the risk to break into the cardiac ablation market. There are more than 5 million people estimated top be afflicted with AF worldwide, including more than 2.5 million in the U.S.

The company believes that the total addressable market for a standalone, minimally invasive cardiac ablation procedure, which the Atrilaze system provides, is more than $2 billion.

MedicalCV has focused all of its attention onto the cardiac ablation market after its exit from the heart valve market last year (MDD, April 14, 2005).

Flores called the latest filing “an important milestone” for the company and added that he believes they are one step closer to bringing the system to market “in the second half of 2006.”