Medical Device Daily Associate

Orqis Medical (Lake Forest, California), a developer of the catheter-based Cancion cardiac recovery system (CRS) to treat congestive heart failure (CHF), reported that the FDA has granted an unconditional approval for researchers to treat up to 200 CHF patients at 40 centers participating in the company’s MOMENTUM (Multicenter trial of the Orqis Medical CRS for the ENhanced Treatment of CHF, Unresponsive to Medical Therapy) pivotal clinical trial.

The company previously reported conditional FDA approval in January to expand the MOMENTUM clinical investigation from eight to 40 centers nationwide (Medical Device Daily, Jan. 14, 2005) after initially receiving a conditional approval for the trial last August (MDD, Aug. 27, 2004).

Ken Charhut, the company’s president and CEO, told Medical Device Daily that unquestionably, the big news here is the panel’s granting of an unconditional approval.

“The Cancion CRS offers the promise of an exciting new percutaneous therapeutic modality to treat patients suffering from CHF,” he said. “Unconditional FDA approval to advance the MOMENTUM clinical investigation will allow us to discover its therapeutic potential.”

Since this is a new device, Charhut said there was a learning curve for the FDA to get comfortable with the system. “Once the FDA became familiar with the device,” he said, “they became more comfortable at lessening the restrictions on the Cancion trial.”

First, the agency agreed to increase the number of centers from eight to 40 and now it has granted the study unconditional status.

The company noted that the Cancion CRS is the first therapy for congestive heart failure based on continuous aortic blood flow augmentation to the descending aorta. The trial will determine efficacy of the therapy to treat patients with acute decompensation resulting from CHF vs. traditional therapies.

Traditional therapies to treat acute CHF include drugs that pull off fluid (diuretics) or cause the heart to pump more strongly (inotropes). In contrast, the Cancion CRS is designed to create an environment that allows the heart to rest while it recovers from an acute decompensation event.

Acutely decompensated heart failure represents 1 million primary and 2.5 million secondary hospital admissions annually. CHF patients suffering an acute episode “have fluid backing up into their lungs and have severe shortness of breath, and that’s what generally brings them into the hospital,” Charhut explained.

Orqis Medical’s device would be used to treat that acute condition to send patients, deemed non-responsive to current medical therapy, home from the hospital.

The extracorporeal, minimally invasive Cancion CRS system provides a circulatory boost while unloading the patient’s heart. Increasing blood velocity down the thoracic aorta, the CRS system consists of two arterial access cannulas, a pump and motor, and a control system. The therapy is applied via routine percutaneous catheterization, making it available to a wider population of CHF patients.

CHF is a chronic disease that affects an estimated 5 million people in the U.S., with a projected cost of $27.9 billion in 2005.

While there are a few similar therapies on the market, including CardiacAssist (Pittsburgh), with the TandemHeart percutaneous ventricular assist system, and CHF Solutions (Brooklyn Park, Minnesota) with its Aquadex system designed to remove excess fluid from fluid-overloaded patients suffering from CHF, Charhut said that his company’s system is unique.

He said the Cancion CRS therapy creates a “rest to recovery” environment for patients and that Orqis is the only company focused on the notion of resting the heart but allowing it to continue to function, and also pointed out that the Cancion is not another ventricular assist device.

“Clearly there are a number of companies that have blood pumps, but they are using them as functional replacements for the heart. We were the ones who discovered that by restoring flow to the descending aorta you could then invoke this therapeutic response,” Charhut said. “We’re really the only ones out there who are utilizing [blood pump] technology in this way to get this effect.”

The ultimate goal of the system, he said, is not to treat chronic advanced-stage CHF patients, but rather, to prevent patients from advancing to the stage where they need dramatic assist devices.

The Cancion, he said, is designed to create an environment for the heart to recover, to break through the downward spiral that the patients have gotten themselves into within this acute episode, relieve that acute episode and then allow them to be discharged from the hospital and put on stable chronic medication.

The therapy can help patients avoid standard treatment with drugs – one that commonly works, at first, until patients gradually become unresponsive. “We’re not eliminating the chronic drugs that are used for heart failure,” Charhut clarified. “Our goal is to get [patients] out of the acute condition, get them out of the hospital and then back responding well to their chronic drugs.”