A Medical Device Daily

Draximage Specialty Pharmaceuticals, the radiopharmaceutical division of Draxis Health (both Montreal), said it has taken “another significant step” in its product development strategy with the filing of its Draximage Sestamibi with European regulatory authorities.

Draximage Sestamibi is a generic kit for the preparation of Tc-99m Sestamibi — an imaging agent used in myocardial perfusion imaging (MPI) to evaluate blood flow to the heart — for injection. It is the largest radiopharmaceutical product in the nuclear medicine market segment.

“Filing Draximage Sestamibi in Europe marks another milestone in our comprehensive plan to pursue major MPI markets globally,” said Jean-Pierre Robert, president of Draxis Specialty Pharmaceuticals. “Draximage Sestamibi is one of our highest-priority growth drivers and the filing of marketing applications in Europe and in the U.S. means that we are one step closer to the realization of our strategy. In addition, we are actively pursuing marketing and distribution partnerships for Sestamibi in Europe and in North America.”

The FDA recently acknowledged receipt and acceptance for review of an Abbreviated New Drug Application for Draximage Sestamibi that was submitted to the agency earlier this year.

The sestamibi kit is used in nuclear medicine imaging to show how well the heart muscle is perfused both at rest and during strenuous activity. The radioisotope Technetium-99m is attached to the sestamibi molecule, forming Tc-99m Sestamibi.

When injected into the bloodstream, this radiopharmaceutical agent is distributed throughout the heart muscle in proportion to the blood flow received by various portions of the heart. Heart images are then obtained using a gamma camera that can detect the Technetium-99m.

Two sets of images are typically taken, one while the patient is at rest and a second set while the patient is under stress, often by exercising on a treadmill or stationary bicycle. The resulting two sets of images are compared with each other to diagnose the presence of coronary heart disease by detecting areas of the heart that may not be receiving normal blood flow.

According to Arlington Medical Resources, in 2005 there were more than 7 million cardiac studies conducted in the U.S. out of a total of some 15 million nuclear medicine procedures, making MPI the most widely performed nuclear medicine scan in the U.S.

Draximage said that, while such cardiac procedures are not nearly so widely performed in Europe, it believes that “significant opportunities do exist in the European market. Recent market research estimates indicate that existing MPI products generate revenues in excess of $50 million in Europe.”

The company said that once its product is approved, it plans to enter the MPI market after key patents for the currently marketed Tc-99m Sestamibi product expire, which is expected to be in 2008 for the U.S. and from this year onward in various European countries.

Draximage said it also plans to file for marketing approvals in additional jurisdictions other than the U.S. and Europe.

BioSTAR launched in Europe, Canada

NMT Medical (Boston) has initiated the commercial launch of its bioabsorbable implant, BioSTAR, in Europe and Canada. The biomaterial, drug and device combination, which received the CE mark in Europe and a Health Products and Food Branch medical device license in Canada (Medical Device Daily ; July 20, 2007), has recently been implanted in several patients in both regions.

NMT said the BioSTAR product, which features the FortaFlex technology created by Organogenesis (Canton, Massachusetts), is designed to close a patent foramen ovale (PFO) using the patient’s natural healing response.

“The launch of BioSTAR is an important milestone for NMT, the medical community and its patients,” said NMT President and CEO John Ahern. “BioSTAR is the first in a new generation of biological implant devices that NMT is developing for treatment of septal heart defects such as PFO and other atrial-level defects.”

He added: “Based on market research, there is a potential for more than 250,000 annual procedures in Europe and Canada for the stroke and transient ischemic attack (TIA) indications, [and] NMT is well-positioned to secure the market leadership position.”

Ahearn said NMT anticipates that BioSTAR “will be widely adopted and considered the implant of choice by cardiologists for patients in need of treatment for septal heart defects ... [and] we have made increased investments in our sales and marketing efforts in preparation for this launch.”

BioSTAR is designed to provide biological closure of defects using the patient’s natural healing response, and 90% to 95% of the implant is expected to be absorbed over time. The device incorporates a purified collagen matrix delivered on the STARFlex alloy framework and uses NMT’s latest Rapid Transport delivery system.

The collagen also is a platform for timed release of biological response modifiers such as genes, cells, proteins and drugs. An elutable heparin substrate has been included in the BioSTAR design and provides a means to minimize the thrombus formation that can occur in intra-cardiac devices.

The BioSTAR implant is offered in 23 mm, 28 mm and 33 mm sizes.