WorldHeart (Oakland, California) reported in February that it plans to acquire all of the assets of MedQuest Products (Salt Lake City), thus bringing together in complementary fashion, heart support devices that beat and those that whir. MedQuest is developing the HeartQuest ventricular assist device (VAD), a magnetically levitated centrifugal rotary blood pump. WorldHeart, in its efforts, is developing the pulsatile Novacor LVAS essentially a system that pulsates somewhat like a beating heart. Thus the merger adds an advanced rotary pump to WorldHeart's VAD platform.

WorldHeart said it would raise up to $23 million in a combined private placement and warrant exercise. In addition, all existing debentures will be converted to common shares of the company. WorldHeart has entered into a private placement with Maverick Venture Management. With deal close, Maverick will invest $12 million in WorldHeart via purchase of roughly 8.9 million common shares at $1.35 a share. Maverick, a majority shareholder of MedQuest, has previously invested around $14 million in that company. WorldHeart will issue 9.3 million common shares to MedQuest in connection with the acquisition.

"Our industry needs both pulsatile and rotary pumps to treat the full spectrum of clinical needs of end- and late-stage heart failure patients," said Jal Jassawalla, president and CEO of WorldHeart. "We believe that pulsatile devices are best suited for end-stage patients with poor ventricular contractility, who require full support, or functional 'replacement,' [while] rotary devices are better suited for late-stage patients, with some contractility, who require only partial support, or 'assist.'" Thus, he said, WorldHeart will now be the only company with "small, silent, next-generation pulsatile and rotary systems under development, as well as having the most durable and reliable current-generation pulsatile device in the market today."

Pratap Khanwilkar, co-founder, president and CEO of MedQuest, will lead the combined firm's rotary pump activities and also head business development for the company. Khanwilkar said, "We believe that our HeartQuest VAD is the most technologically advanced rotary pump under development. Our magnetically-levitated rotor results in a pump with no moving parts subject to wear, resulting in a small device expected to provide multiyear support over a wide range of flows." He called combination of the two systems "critical in expanding the destination therapy market."

With the acquisition, WorldHeart's product platform will include the Novacor LVAS, currently sold for a bridge-to-transplant indication in the U.S., Canada, the European Union and Japan; the Novacor II, a small, bearingless, pulsatile VAD under development and expected to begin animal trials this year, the company said; and the HeartQuest VAD, a small rotary pump in pre-clinical animal and bench testing, with an initial feasibility clinical trial expected to be initiated by the beginning of next year.

Other companies in the ventricular assist device sector include A-Med Systems (West Sacramento, California), Arrow International (Reading, Pennsylvania), MicroMed Technology (Houston), Thoratec (Pleasanton, California), Vascor (Pittsburgh, Pennsylvania) and VentraCor (Sydney, Australia). Ventracor recently reported receiving approval to begin UK enrollment in a trial to support CE-marking of its VentrAssist LVAS.

Cypher follows Taxus to 1 million

The Cypher sirolimus-eluting coronary stent from Cordis (Miami Lakes, Florida), has now been implanted in more than 1 million cardiac patients around the world since its first market introduction in Europe in April 2002. The total number of stents implanted in these patients is about 1.5 million stents. Cordis, a unit of Johnson & Johnson (J&J; New Brunswick, New Jersey), said the Cypher stent is "one of the industry's most quickly adopted medical technologies and has been key in fundamentally changing the practice of interventional cardiology."

Martin Leon, MD, of Columbia-Presbyterian Hospital (New York), said, "This medical technology of drug-eluting stents has introduced a new era in cardiology where patients can be treated less invasively and have a better chance of avoiding a repeat cardiac procedure." Leon was the first physician in the U.S. to treat a patient with the Cypher stent after its approval by the FDA in April 2003.

The report from Cordis follows that of Boston Scientific (Natick, Massachusetts), which said in January that it had reached the 1 million mark of implantations of its Taxus drug-eluting stent (DES). The Taxus received FDA approval in March 2004.

Medinol, pharma firm in stent accord

Ariad Pharmaceuticals (Cambridge, Massachusetts) has entered into non-exclusive agreements with cardiovascular device maker Medinol (Tel Aviv, Israel) to develop and commercialize stents and other medical devices to deliver Ariad's mTOR inhibitor, AP23573, to prevent reblockage of injured vessels following stent-assisted angioplasty. Under the agreement, Ariad is eligible to receive license fees and regulatory, clinical and commercial milestones of up to $39.25 million, if two products are developed, plus royalties on worldwide product sales.

Ariad will be responsible for supplying AP23573 to Medinol, and Medinol will be responsible for the development and commercialization of the medical devices delivering the compound. Ariad said it has retained the right to enter into two additional non-exclusive agreements to develop and commercialize AP23573 in drug-delivery devices for vascular disease. Additional terms were not disclosed.

The small-molecule drug AP23573 starves cancer cells and shrinks tumors by inhibiting the cell-signaling protein, mTOR, which regulates the response of tumor cells to nutrients and growth factors, and controls tumor blood supply and angiogenesis through effects on vascular endothelial growth factor (VEGF).

AP23573 also blocks the proliferation and migration of vascular smooth muscle cells, the primary cause of narrowing and reblockage of injured arteries, and is an analog of sirolimus, another mTOR inhibitor that has been approved for use on drug-eluting stents (DES), including Cordis' Cypher stent, the first DES to be approved in the U.S. AP23573 is currently in Phase II clinical development in patients with solid tumors and hematologic cancers.

"We are pleased to have one of the most innovative and successful medical device companies as our first partner to develop and commercialize drug-delivery stents incorporating AP23573," said Harvey Berger, MD, chairman and chief executive of Ariad. "We believe that Medinol has the design and manufacturing capabilities to develop differentiated stent platforms and polymer formulations that will enable its next-generation stents to achieve substantial penetration in a market that is estimated to grow to over $6 billion by 2008."

Abbott sets 'landmark' carotid stent trial

Abbott Laboratories (Abbott Park, Illinois) said it would begin the first trial of its kind to assess the benefits of using stents in the neck arteries of likely stroke patients who have not shown symptoms of the disease. Stroke is the third leading cause of death in the U.S. If results of the new trial, dubbed ACT I for Carotid Angioplasty and Stenting vs. Endarterectomy in Asymptomatic Patients with Significant Extra-cranial Carotid Occlusive Disease Trial are successful, asymptomatic patients who normally would have surgery could have the alternative of a minimally invasive carotid stenting procedure. The trial will compare stenting to surgery in the carotid arteries of such patients who normally would be referred for surgery for carotid artery disease (CAD). About one-fourth of all strokes are caused by CAD.

Abbott, via its Abbott Vascular Devices (Redwood City, California) division, is currently awaiting U.S. regulatory approval for a carotid stent for high-risk patients for whom surgery is not recommended and expects a decision in 2Q05. That approval is for the same system being used in the ACT I trial, the Xact carotid stent system coupled with the Embo-shield embolic protection system

Physicians use these minimally invasive devices to treat carotid artery disease by placing a stent in the carotid artery to restore unrestrained blood flow to the brain. The stent is brought into position in the carotid artery via thin catheters that are threaded through the vascular system from a small access site typically made in the femoral artery in the groin. A special device called an embolic protection filter is opened up like an umbrella downstream from the stenting procedure to protect the patient's brain by catching emboli (plaque) that may be dislodged during the procedure.

Northfield raises $77.6 million

Despite facing continuing regulatory barriers, oxygen therapeutics developer Northfield Laboratories (Evanston, Illinois) last month raised $77.6 million in an offering of common stock. The primary offering raised about $66.5 million, with the sale of over-allotment options to the underwriters bringing in an additional $10.1 million. UBS Investment Bank was the sole book-running manager in the offering, with SG Cowen as co-lead manager and Harris Nesbitt as co-manager.

Northfield is developing PolyHeme, an oxygen-carrying blood substitute for the treatment of urgent, large-volume blood loss in trauma and resultant surgical settings. It is a solution of chemically modified human hemoglobin that requires no cross-matching and thus is compatible with all blood types. Enrollment is under way in a pivotal Phase III trial, initially in the pre-hospital setting.