CDU Associate

St. Jude Medical (St. Paul, Minnesota) finally received its invitation from the FDA in late June to the cardiac resynchronization therapy defibrillator (CRT-D) party. While the late arrival joined the festivities nearly two years after competitors Guidant (Indianapolis, Indiana) and Medtronic (Minneapolis, Minnesota), it said it doesn't plan to enter the scene quietly and already has begun an aggressive rollout of the product in the U.S.

The company announced June 30 the approval of two of the sophisticated systems that not only regulate an irregular heartbeat but also resynchronize the right and left ventricles in patients with congestive heart failure.

The FDA approved both the Epic HF and Atlas+ HF ICDs and the QuickSite left-heart pacing lead. The approvals were based on the results of the Resynchronization HemodYnamic Treatment for Heart Failure Management (RHYTHM) ICD study, which demonstrated a significant improvement in Peak VO₂, exercise duration, New York Heart Association (NYHA) class and quality of life in patients treated with CRT. Those results were reported on at the American College of Cardiology (Bethesda, Maryland) meeting in New Orleans this past March.

The systems are indicated to provide a reduction of the symptoms of moderate to severe heart failure (NYHA Functional Class III or IV) in those patients who remain symptomatic despite stable, optimal medical therapy, and have a left-ventricular ejection fraction less than or equal to 35% and a prolonged QRS duration. The RHYTHM ICD study was a prospective, double-blinded, randomized control, multicenter clinical trial enrolling 205 patients. An additional 162 patients were enrolled in the QuickSite lead phase of the study.

Full U.S. market release of the systems will begin immediately, and the company said it believes it has adequate inventories on hand in support of the U.S. market release of these products. "St. Jude Medical's state-of-the-art CRT-D device system allows fast, easy implantation and extremely flexible device feature options for patients suffering the debilitating effects of ventricular dyssynchrony and heart failure," said Michael Coyle, president of the company's Cardiac Rhythm Management business. "Our seamlessly integrated system of delivery tools, leads and CRT devices offers the latest technology advances to optimize cardiac resynchronization therapy."

Peter Gove, vice president of corporate communications for St. Jude, said the newly approved CRT system provides physicians a choice of two devices that combine pacemaker therapy, defibrillation therapy and biventricular stimulation to treat the complexities of heart failure. "The Epic is the [world's] smallest CRT-D and the Atlas has the highest output [36 joules]," he told Cardiovascular Device Update. He also noted that both systems "have very interesting diagnostics, they're thin [and] they're supported by an excellent lead. That system together we think is going to be attractive to a lot of clinicians."

According to Gove, St. Jude did not plan to launch the two products at the same time as part of any deliberate marketing strategy. "They were all part of the same [FDA] filing," he said, adding that "it might have been part of the strategy for the filing, which is to have both a smaller device for some patients and a more powerful device for others and combine it with a very good lead." He said this approval, coupled with the recent launch of several new introducers, provides the company's customers with a "complete system approach to CRT-D."

These devices monitor every heartbeat and provide biventricular pacing to reduce the symptoms of moderate to severe heart failure. To help ensure effective resynchronization therapy, the devices can be programmed to use Negative AV/PV Hysteresis to automatically shorten the AV/PV delay when needed and promote biventricular pacing.

The devices also feature flexible programming options available for both defibrillation threshold (DFT) and sensing management. The CRT-Ds also deliver anti-tachycardia pacing, cardioversion and defibrillation to immediately treat life-threatening ventricular tachyarrhythmias, which can lead to sudden cardiac death.

Follow-ups for patients implanted with the St. Jude devices are simplified with the company's Housecall Plus system, a remote monitoring system that offers real-time data transmissions and live interaction with a medical professional via telephone to evaluate the patient's heart and device. Physicians receive the same real-time data and complete diagnostics from a Housecall Plus system monitoring session as they would from an in-office visit, the company said.

Med-tech analyst Thomas Gunderson of Piper Jaffray (Minneapolis, Minnesota) wrote in a research report prior to the announcement of the approval that he believed St. Jude would price its new systems at a premium to its competitors. "We believe St. Jude will launch its CRT-D systems at a relatively high list price, with a system price of over $35,000 vs. a current competitive average price of $32,000 per system, signaling to Medtronic and Guidant that St. Jude intends to compete on features, not price," he said.

While acknowledging that premium pricing might be the case with some accounts in the U.S., Gove indicated that would not be the company's primary strategy for its U.S. launch. "Our strategy is that we have 17% of the standard ICD market, and we have 25% of the pacing market, and these are the same physicians. We have relationships with these physicians, we have very good technology [that is] proven in Europe and we expect to gain market share [in the U.S.]."

As for rollout in the U.S., Gove indicated that St. Jude Medical had already initiated market release, which he said the company anticipates will go smoothly. "I think what's most important is these products have been available in Europe for more than a year." This, he said, provides St. Jude with experience, clinician feedback, trained reps and inventory. "So we literally shipped last night, and there will be implants today."

In May, the company reported that U.S. regulatory approval of the two CRT-D devices defibrillators would be delayed from the originally projected date, which the company had hoped would be the week before the late-May meeting of the Heart Rhythm Society (formerly the North American Society for Pacing and Electrophysiology; Natick, Massachusetts) in San Francisco, California. It still managed to receive approval at the tail end of the second quarter, as it had projected at that time.

In a separate but related news release issued on July 1, St. Jude said it had submitted a premarket approval supplement (PMAS) to the FDA for addition of the V-V (ventricle-to-ventricle) timing feature to the biventricular pacing capabilities available in its CRT-D product line, including both the Epic and Atlas devices. The results of the V-V timing optimization phase of the RHYTHM ICD clinical trial served as the basis for the submission, the company said.

"Programmable V-V timing is an important feature of our high-voltage cardiac resynchronization device offerings that has proved valuable to our international physician customer base," Coyle said in the company statement. "We look forward to bringing this therapy optimization programming parameter to our U.S. customer base."